[Federal Register Volume 82, Number 220 (Thursday, November 16, 2017)]
[Rules and Regulations]
[Pages 53568-54229]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-24067]



[[Page 53567]]

Vol. 82

Thursday,

No. 220

November 16, 2017

Part II

Book 2 of 3 Books

Pages 53567-54230





Department of Health and Human Services





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Centers for Medicare & Medicaid Services



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42 CFR Part 414



 Medicare Program; CY 2018 Updates to the Quality Payment Program; and 
Quality Payment Program: Extreme and Uncontrollable Circumstance Policy 
for the Transition Year; Rule

Federal Register / Vol. 82 , No. 220 / Thursday, November 16, 2017 / 
Rules and Regulations

[[Page 53568]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 414

[CMS-5522-FC and IFC]
RIN 0938-AT13


Medicare Program; CY 2018 Updates to the Quality Payment Program; 
and Quality Payment Program: Extreme and Uncontrollable Circumstance 
Policy for the Transition Year

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Final rule with comment period and interim final rule with 
comment period.

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SUMMARY: The Medicare Access and CHIP Reauthorization Act of 2015 
(MACRA) established the Quality Payment Program for eligible 
clinicians. Under the Quality Payment Program, eligible clinicians can 
participate via one of two tracks: Advanced Alternative Payment Models 
(APMs); or the Merit-based Incentive Payment System (MIPS). We began 
implementing the Quality Payment Program through rulemaking for 
calendar year (CY) 2017. This final rule with comment period provides 
updates for the second and future years of the Quality Payment Program.
    In addition, we also are issuing an interim final rule with comment 
period (IFC) that addresses extreme and uncontrollable circumstances 
MIPS eligible clinicians may face as a result of widespread 
catastrophic events affecting a region or locale in CY 2017, such as 
Hurricanes Irma, Harvey and Maria.

DATES: 
    Effective date: These provisions of this final rule with comment 
period and interim final rule with comment period are effective on 
January 1, 2018.
    Comment date: To be assured consideration, comments must be 
received at one of the addresses provided below, no later than 5 p.m. 
on January 1, 2018.

ADDRESSES: In commenting, please refer to file code CMS-5522-FC when 
commenting on issues in the final rule with comment period, and CMS-
5522-IFC when commenting on issues in the interim final rule with 
comment period. Because of staff and resource limitations, we cannot 
accept comments by facsimile (FAX) transmission. You may submit 
comments in one of four ways (please choose only one of the ways 
listed):
    1. Electronically. You may submit electronic comments on this 
regulation to http://www.regulations.gov. Follow the ``Submit a 
comment'' instructions.
    2. By regular mail. You may mail written comments to the following 
address ONLY: Centers for Medicare & Medicaid Services, Department of 
Health and Human Services, Attention: CMS-5522-FC or CMS-5522-IFC (as 
appropriate), P.O. Box 8016, Baltimore, MD 21244-8016.
    Please allow sufficient time for mailed comments to be received 
before the close of the comment period.
    3. By express or overnight mail. You may send written comments to 
the following address ONLY: Centers for Medicare & Medicaid Services, 
Department of Health and Human Services, Attention: CMS-5522-FC or CMS-
5522-IFC (as appropriate), Mail Stop C4-26-05, 7500 Security Boulevard, 
Baltimore, MD 21244-1850.
    4. By hand or courier. Alternatively, you may deliver (by hand or 
courier) your written comments ONLY to the following addresses prior to 
the close of the comment period:
    a. For delivery in Washington, DC-- Centers for Medicare & Medicaid 
Services, Department of Health and Human Services, Room 445-G, Hubert 
H. Humphrey Building, 200 Independence Avenue SW., Washington, DC 
20201.
    (Because access to the interior of the Hubert H. Humphrey Building 
is not readily available to persons without Federal government 
identification, commenters are encouraged to leave their comments in 
the CMS drop slots located in the main lobby of the building. A stamp-
in clock is available for persons wishing to retain a proof of filing 
by stamping in and retaining an extra copy of the comments being 
filed.)
    b. For delivery in Baltimore, MD-- Centers for Medicare & Medicaid 
Services, Department of Health and Human Services, 7500 Security 
Boulevard, Baltimore, MD 21244-1850.
    If you intend to deliver your comments to the Baltimore address, 
call telephone number (410) 786-7195 in advance to schedule your 
arrival with one of our staff members. Comments erroneously mailed to 
the addresses indicated as appropriate for hand or courier delivery may 
be delayed and received after the comment period.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT:
    Molly MacHarris, (410) 786-4461, for inquiries related to MIPS.
    Benjamin Chin, (410) 786-0679, for inquiries related to APMs.

SUPPLEMENTARY INFORMATION: 

Table of Contents

I. Executive Summary and Background
    A. Overview
    B. Quality Payment Program Strategic Objectives
    C. One Quality Payment Program
    D. Summary of the Major Provisions
    1. Quality Payment Program Year 2
    2. Small Practices
    3. Summary of Major Provisions for Advanced Alternative Payment 
Models (Advanced APMs)
    4. Summary of Major Provisions for the Merit-Based Incentive 
Payment System (MIPS)
    E. Payment Adjustments
    F. Benefits and Costs of the Final Rule With Comment Period
    G. Automatic Extreme and Uncontrollable Circumstance Policy 
Interim Final Rule With Comment Period
    H. Stakeholder Input
II. Summary of the Provisions of the Proposed Regulations, and 
Analysis of and Responses to Public Comments
    A. Introduction
    B. Definitions
    C. MIPS Program Details
    1. MIPS Eligible Clinicians
    2. Exclusions
    3. Group Reporting
    4. Virtual Groups
    5. MIPS Performance Period
    6. MIPS Category Measures and Activities
    7. MIPS Final Score Methodology
    8. MIPS Payment Adjustments
    9. Review and Correction of MIPS Final Score
    10. Third Party Data Submission
    11. Public Reporting on Physician Compare
    D. Overview of the APM Incentive
    1. Overview
    2. Terms and Definitions
    3. Regulation Text Changes
    4. Advanced APMs
    5. Qualifying APM Participant (QP) and Partial QP Determinations
    6. All-Payer Combination Option
    7. Physician-Focused Payment Models (PFPMs)
III. Quality Payment Program: Extreme and Uncontrollable 
Circumstances Policy for the Transition Year Interim Final Rule With 
Comment Period
    A. Background
    B. Changes to the Extreme and Uncontrollable Circumstances 
Policies for the MIPS Transition Year
    C. Changes to the Final Score and Policies for Redistributing 
the Performance Category Weights for the Transition Year
    D. Changes to the APM Scoring Standard for MIPS Eligible 
Clinicians in MIPS APMs for the Transition Year
    E. Waiver of Proposed Rulemaking for Provisions Related to 
Extreme and Uncontrollable Circumstances
IV. Collection of Information Requirements
    A. Wage Estimates
    B. Framework for Understanding the Burden of MIPS Data 
Submission

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    C. ICR Regarding Burden for Virtual Group Election (Sec.  
414.1315)
    D. ICR Regarding Burden for Election of Facility-Based 
Measurement (Sec.  414.1380(e))
    E. ICRs Regarding Burden for Third-Party Reporting (Sec.  
414.1400)
    F. ICRs Regarding the Quality Performance Category (Sec. Sec.  
414.1330 and 414.1335)
    G. ICRs Regarding Burden Estimate for Advancing Care Information 
Data (Sec.  414.1375)
    H. ICR Regarding Burden for Improvement Activities Submission 
(Sec.  414.1355)
    I. ICR Regarding Burden for Nomination of Improvement Activities 
(Sec.  414.1360)
    J. ICRs Regarding Burden for Cost (Sec.  414.1350)
    K. ICR Regarding Partial QP Elections (Sec.  414.1430)
    L. ICRs Regarding Other Payer Advanced APM Determinations: 
Payer-Initiated Process (Sec.  414.1440) and Medicaid Specific 
Eligible Clinician Initiated Process (Sec.  414.1445)
    M. ICRs Regarding Burden for Voluntary Participants To Elect Opt 
Out of Performance Data Display on Physician Compare (Sec.  
414.1395)
    N. Summary of Annual Burden Estimates
    O. Submission of PRA-Related Comments
    P. Collection of Information Requirements for the Interim Final 
Rule With Comment Period: Medicare Program; Quality Payment Program: 
Extreme and Uncontrollable Circumstances Policy for the Transition 
Year
V. Response to Comments
VI. Regulatory Impact Analysis
    A. Statement of Need
    B. Overall Impact
    C. Changes in Medicare Payments
    D. Impact on Beneficiaries
    E. Regulatory Review Costs
    F. Accounting Statement
    G. Regulatory Impact Statement for Interim Final Rule With 
Comment Period: Medicare Program; Quality Payment Program: Extreme 
and Uncontrollable Circumstance Policy for the Transition Year

Acronyms

    Because of the many terms to which we refer by acronym in this 
rule, we are listing the acronyms used and their corresponding meanings 
in alphabetical order below:

ABCTM Achievable Benchmark of Care
ACO Accountable Care Organization
API Application Programming Interface
APM Alternative Payment Model
APRN Advanced Practice Registered Nurse
ASC Ambulatory Surgical Center
ASPE HHS' Office of the Assistant Secretary for Planning and 
Evaluation
BPCI Bundled Payments for Care Improvement
CAH Critical Access Hospital
CAHPS Consumer Assessment of Healthcare Providers and Systems
CBSA Core Based Statistical Area
CEHRT Certified EHR Technology
CFR Code of Federal Regulations
CHIP Children's Health Insurance Program
CJR Comprehensive Care for Joint Replacement
COI Collection of Information
CPR Customary, Prevailing, and Reasonable
CPS Composite Performance Score
CPT Current Procedural Terminology
CQM Clinical Quality Measure
CY Calendar Year
eCQM Electronic Clinical Quality Measure
ED Emergency Department
EHR Electronic Health Record
EP Eligible Professional
ESRD End-Stage Renal Disease
FFS Fee-for-Service
FR Federal Register
FQHC Federally Qualified Health Center
GAO Government Accountability Office
HCC Hierarchical Condition Category
HIE Health Information Exchange
HIPAA Health Insurance Portability and Accountability Act of 1996
HITECH Health Information Technology for Economic and Clinical 
Health
HPSA Health Professional Shortage Area
HHS Department of Health & Human Services
HRSA Health Resources and Services Administration
IHS Indian Health Service
IT Information Technology
LDO Large Dialysis Organization
MACRA Medicare Access and CHIP Reauthorization Act of 2015
MEI Medicare Economic Index
MIPAA Medicare Improvements for Patients and Providers Act of 2008
MIPS Merit-based Incentive Payment System
MLR Minimum Loss Rate
MSPB Medicare Spending per Beneficiary
MSR Minimum Savings Rate
MUA Medically Underserved Area
NPI National Provider Identifier
OCM Oncology Care Model
ONC Office of the National Coordinator for Health Information 
Technology
PECOS Medicare Provider Enrollment, Chain, and Ownership System
PFPMs Physician-Focused Payment Models
PFS Physician Fee Schedule
PHI Protected Health Information
PHS Public Health Service
PQRS Physician Quality Reporting System
PTAC Physician-Focused Payment Model Technical Advisory Committee
QCDR Qualified Clinical Data Registry
QP Qualifying APM Participant
QRDA Quality Reporting Document Architecture
QRUR Quality and Resource Use Reports
RBRVS Resource-Based Relative Value Scale
RFI Request for Information
RHC Rural Health Clinic
RIA Regulatory Impact Analysis
RVU Relative Value Unit
SGR Sustainable Growth Rate
TCPI Transforming Clinical Practice Initiative
TIN Tax Identification Number
VBP Value-Based Purchasing
VM Value-Based Payment Modifier
VPS Volume Performance Standard

I. Executive Summary and Background

A. Overview

    This final rule with comment period makes payment and policy 
changes to the Quality Payment Program. The Medicare Access and CHIP 
Reauthorization Act of 2015 (MACRA) (Pub. L. 114-10, enacted April 16, 
2015) amended Title XVIII of the Social Security Act (the Act) to 
repeal the Medicare sustainable growth rate (SGR) formula, to 
reauthorize the Children's Health Insurance Program (CHIP), and to 
strengthen Medicare access by improving physician and other clinician 
payments and making other improvements. The MACRA advances a forward-
looking, coordinated framework for clinicians to successfully take part 
in the Quality Payment Program that rewards value and outcomes in one 
of two ways:
     Advanced Alternative Payment Models (Advanced APMs).
     Merit-based Incentive Payment System (MIPS).
    Our goal is to support patients and clinicians in making their own 
decisions about health care using data driven insights, increasingly 
aligned and meaningful quality measures, and innovative technology. To 
implement this vision, the Quality Payment Program emphasizes high-
value care and patient outcomes while minimizing burden on eligible 
clinicians. The Quality Payment Program is also designed to be 
flexible, transparent, and structured to improve over time with input 
from clinicians, patients, and other stakeholders.
    In today's health care system, we often pay doctors and other 
clinicians based on the number of services they perform rather than 
patient health outcomes. The good work that clinicians do is not 
limited to conducting tests or writing prescriptions, but also taking 
the time to have a conversation with a patient about test results, 
being available to a patient through telehealth or expanded hours, 
coordinating medicine and treatments to avoid confusion or errors, and 
developing care plans.
    The Quality Payment Program takes a comprehensive approach to 
payment by basing consideration of quality on a set of evidenced-based 
measures that were primarily developed by clinicians, thus encouraging 
improvement in clinical practice and supporting by advances in 
technology that allow for the easy exchange of information. The Quality 
Payment Program also offers special incentives for those participating 
in certain innovative models of care that

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provide an alternative to fee-for-service payment.
    We have sought and will continue to seek feedback from the health 
care community through various public avenues such as rulemaking, 
listening sessions and stakeholder engagement. We understand that 
technology, infrastructure, physician support systems, and clinical 
practices will change over the next few years and are committed to 
refine our policies for the Quality Payment Program with those factors 
in mind.
    We are aware of the diversity among clinician practices in their 
experience with quality-based payments and expect the Quality Payment 
Program to evolve over multiple years. The groundwork has been laid for 
expansion toward an innovative, patient-centered, health system that is 
both outcome focused and resource effective. A system that leverages 
health information technology to support clinicians and patients and 
builds collaboration across care settings. The Quality Payment Program: 
(1) Supports care improvement by focusing on better outcomes for 
patients, and preserving the independent clinical practice; (2) 
promotes the adoption of APMs that align incentives for high-quality, 
low-cost care across healthcare stakeholders; and (3) advances existing 
delivery system reform efforts, including ensuring a smooth transition 
to a healthcare system that promotes high-value, efficient care through 
unification of CMS legacy programs.
    In the Merit-based Incentive Payment System (MIPS) and Alternative 
Payment Model (APM) Incentive under the Physician Fee Schedule, and 
Criteria for Physician-Focused Payment Models final rule with comment 
period (81 FR 77008, November 4, 2016), referred to as the ``CY 2017 
Quality Payment Program final rule,'' we established incentives for 
participation in Advanced APMs, supporting the goals of transitioning 
from fee-for-service (FFS) payments to payments for quality and value. 
The CY 2017 Quality Payment Program final rule included definitions and 
processes to determine Qualifying APM Participants (QPs) in Advanced 
APMs. The CY 2017 Quality Payment Program final rule also established 
the criteria for use by the Physician-Focused Payment Model Technical 
Advisory Committee (PTAC) in making comments and recommendations to the 
Secretary on proposals for physician-focused payment models (PFPMs).
    The CY 2017 Quality Payment Program final rule also established 
policies to implement MIPS, which consolidated certain aspects of the 
Physician Quality Reporting System (PQRS), the Physician Value-based 
Payment Modifier (VM), and the Medicare Electronic Health Record (EHR) 
Incentive Program for Eligible Professionals (EPs) and made CY 2017 the 
transition year for clinicians under the Quality Payment Program. As 
prescribed by MACRA, MIPS focuses on the following: (1) Quality--
including a set of evidence-based, specialty-specific standards; (2) 
cost; (3) practice-based improvement activities; and (4) use of 
certified electronic health record (EHR) technology (CEHRT) to support 
interoperability and advanced quality objectives in a single, cohesive 
program that avoids redundancies.
    This CY 2018 final rule with comment period continues to build and 
improve upon our transition year policies, as well as, address elements 
of MACRA that were not included in the first year of the program, 
including virtual groups, beginning with the CY 2019 performance period 
facility-based measurement, and improvement scoring. This final rule 
with comment period implements policies for ``Quality Payment Program 
Year 2,'' some of which will continue into subsequent years of the 
Quality Payment Program.
    We have also included an interim final rule with comment period to 
establish an automatic extreme and uncontrollable circumstance policy 
for the 2017 MIPS performance period that recognizes recent hurricanes 
(Harvey, Irma, and Maria) and other natural disasters can effectively 
impede a MIPS eligible clinician's ability to participate in MIPS.

B. Quality Payment Program Strategic Objectives

    After extensive outreach with clinicians, patients and other 
stakeholders, we created 7 strategic objectives to drive continued 
progress and improvement. These objectives help guide our final 
policies and future rulemaking in order to design, implement, and 
advance a Quality Payment Program that aims to improve health outcomes, 
promote efficiency, minimize burden of participation, and provide 
fairness and transparency in operations.
    These strategic objectives are as follows: (1) To improve 
beneficiary outcomes and engage patients through patient-centered 
Advanced APM and MIPS policies; (2) to enhance clinician experience 
through flexible and transparent program design and interactions with 
easy-to-use program tools; (3) to increase the availability and 
adoption of robust Advanced APMs; (4) to promote program understanding 
and maximize participation through customized communication, education, 
outreach and support that meet the needs of the diversity of physician 
practices and patients, especially the unique needs of small practices; 
(5) to improve data and information sharing on program performance to 
provide accurate, timely, and actionable feedback to clinicians and 
other stakeholders; (6) to deliver IT systems capabilities that meet 
the needs of users for data submission, reporting, and improvement and 
are seamless, efficient and valuable on the front and back-end; and (7) 
to ensure operation excellence in program implementation and ongoing 
development; and to design the program in a manner that allows smaller 
independent and rural practices to be successful. More information on 
these objectives and the Quality Payment Program can be found at 
qpp.cms.gov.
    Stakeholder feedback is the hallmark of the Quality Payment 
Program. We solicited and reviewed nearly 1,300 comments and had over 
100,000 physicians and other stakeholders attend our outreach sessions 
to help inform our policies for Quality Payment Program Year 2. We have 
set ambitious yet achievable goals for those clinicians interested in 
APMs, as they are a vital part of bending the Medicare cost curve by 
encouraging the delivery of high-quality, low-cost care. To allow this 
program to work for all stakeholders, we further recognize that we must 
provide ongoing education, support, and technical assistance so that 
clinicians can understand program requirements, use available tools to 
enhance their practices, and improve quality and progress toward 
participation in APMs if that is the best choice for their practice. 
Finally, we understand that we must achieve excellence in program 
management, focusing on customer needs while also promoting problem-
solving, teamwork, and leadership to provide continuous improvements in 
the Quality Payment Program.

C. One Quality Payment Program

    Clinicians have told us that they do not separate their patient 
care into domains, and that the Quality Payment Program needs to 
reflect typical clinical workflows in order to achieve its goal of 
better patient care. Advanced APMs, the focus of one pathway of the 
Quality Payment Program, contribute to better care and smarter spending 
by allowing physicians and other clinicians to deliver coordinated, 
customized, high-value care to their patients in a streamlined and 
cost-effective manner. Within MIPS, the second pathway of the Quality 
Payment Program, we believe that integration into typical clinical

[[Page 53571]]

workflows can best be accomplished by making connections across the 
four statutory pillars of the MIPS incentive structure. Those four 
pillars are: (1) Quality; (2) clinical practice improvement activities 
(referred to as ``improvement activities''); (3) meaningful use of 
CEHRT (referred to as ``advancing care information''); and (4) resource 
use (referred to as ``cost'').
    Although there are two separate pathways within the Quality Payment 
Program, Advanced APMs and MIPS both contribute toward the goal of 
seamless integration of the Quality Payment Program into clinical 
practice workflows. Advanced APMs promote this seamless integration by 
way of payment methodology and design that incentivize care 
coordination. The MIPS builds the capacity of eligible clinicians 
across the four pillars of MIPS to prepare them for participation in 
APMs in later years of the Quality Payment Program. Indeed, the bedrock 
of the Quality Payment Program is high-value, patient-centered care, 
informed by useful feedback, in a continuous cycle of improvement. The 
principal way that MIPS measures quality of care is through a set of 
clinical quality measures (CQMs) from which MIPS eligible clinicians 
can select. The CQMs are evidence-based, and the vast majority are 
created or supported by clinicians. Over time, the portfolio of quality 
measures will grow and develop, driving towards outcomes that are of 
the greatest importance to patients and clinicians and away from 
process, or ``check the box'' type measures.
    Through MIPS, we have the opportunity to measure clinical and 
patient outcomes, not only through evidence-based quality measures, but 
also by accounting for activities that clinicians and patients 
themselves identify: Namely, practice-driven quality improvement. MIPS 
also requires us to assess whether CEHRT is used in a meaningful way 
and based on significant feedback, this area was simplified to support 
the exchange of patient information, engagement of patients in their 
own care through technology, and the way technology specifically 
supports the quality goals selected by the practice. And lastly, MIPS 
requires us to measure the cost of services provided through the cost 
performance category, which will contribute to a MIPS eligible 
clinician's final score beginning in the second year of the MIPS.
    We realize the Quality Payment Program is a big change. In this 
final rule with comment period, we continue the slow ramp-up of the 
Quality Payment Program by establishing special policies for MIPS Year 
2 aimed at encouraging successful participation in the program while 
reducing burden, reducing the number of clinicians required to 
participate, and preparing clinicians for the CY 2019 performance 
period (CY 2021 payment year). Our hope is for the program to evolve to 
the point where all the clinical activities captured in MIPS across the 
four performance categories reflect the single, unified goal of quality 
improvement.

D. Summary of the Major Provisions

1. Quality Payment Program Year 2
    We believe the second year of the Quality Payment Program should 
build upon the foundation that has been established which provides a 
trajectory for clinicians to value-based care. A second year to ramp-up 
the program will continue to help build upon the iterative learning and 
development of year 1 in preparation for a robust program in year 3.
2. Small Practices
    The support of small, independent practices remains an important 
thematic objective for the implementation of the Quality Payment 
Program and is expected to be carried throughout future rulemaking. 
Many small practices did not have to participate in MIPS during the 
transition year due to the low-volume threshold, which was set for the 
CY 2017 performance period at less than or equal to $30,000 in Medicare 
Part B allowed charges or less than or equal to 100 Medicare Part B 
patients. We have heard feedback that many small practices still face 
challenges in their ability to participate in the program. We are 
implementing additional flexibilities for Year 2 including: 
Implementing the virtual groups provisions; increasing the low-volume 
threshold to less than or equal to $90,000 in Medicare Part B allowed 
charges or less than or equal to 200 Medicare Part B patients; adding a 
significant hardship exception from the advancing care information 
performance category for MIPS eligible clinicians in small practices; 
providing 3 points even if small practices submit quality measures 
below data completeness standards; and providing bonus points that are 
added to the final scores of MIPS eligible clinicians who are in small 
practices. We believe that these additional flexibilities and reduction 
in barriers will further enhance the ability of small practices to 
participate successfully in the Quality Payment Program.
    In keeping with the objectives to provide education about the 
Quality Payment Program and maximize participation, and as mandated by 
the statute, during a period of 5 years, $100 million in funding was 
provided for technical assistance to be available to provide guidance 
and assistance to MIPS eligible clinicians in small practices through 
contracts with regional health collaboratives, and others. Guidance and 
assistance on the MIPS performance categories or the transition to APM 
participation will be available to MIPS eligible clinicians in 
practices of 15 or fewer clinicians with priority given to practices 
located in rural areas or medically underserved areas (MUAs), and 
practices with low MIPS final scores. More information on the technical 
assistance support available to small practices can be found at https://qpp.cms.gov/docs/QPP_Support_for_Small_Practices.pdf.
    We have also performed an updated regulatory impact analysis, 
accounting for flexibilities, many of which are continuing into the 
Quality Payment Program Year 2, that have been created to ease the 
burden for small and solo practices.
3. Summary of Major Provisions for Advanced Alternative Payment Models 
(Advanced APMs)
a. Overview
    APMs represent an important step forward in our efforts to move our 
healthcare system from volume-based to value-based care. Our existing 
APM policies provide opportunities that support state flexibility, 
local leadership, regulatory relief, and innovative approaches to 
improve quality, accessibility, and affordability.
    APMs that meet the criteria to be Advanced APMs provide the pathway 
through which eligible clinicians, many of whom who would otherwise 
fall under the MIPS, can become Qualifying APM Participants (QPs), 
thereby earning incentives for their Advanced APM participation. In the 
CY 2017 Quality Payment Program final rule, we estimated that 70,000 to 
120,000 eligible clinicians would be QPs for payment year 2019 based on 
Advanced APM participation in performance year 2017 (81 FR 77516). With 
new Advanced APMs expected to be available for participation in 2018, 
including the Medicare ACO Track 1 Plus (1+) Model, and the addition of 
new participants for some current Advanced APMs, such as the Next 
Generation ACO Model and Comprehensive Primary Care Plus (CPC+) Model, 
we anticipate higher numbers of QPs in subsequent years of the program. 
We currently estimate that approximately 185,000 to 250,000

[[Page 53572]]

eligible clinicians may become QPs for payment year 2020 based on 
Advanced APM participation in performance year 2018.
b. Advanced APMs
    In the CY 2017 Quality Payment Program final rule, to be considered 
an Advanced APM, we finalized that an APM must meet all three of the 
following criteria, as required under section 1833(z)(3)(D) of the Act: 
(1) The APM must require participants to use CEHRT; (2) The APM must 
provide for payment for covered professional services based on quality 
measures comparable to those in the quality performance category under 
MIPS; and (3) The APM must either require that participating APM 
Entities bear risk for monetary losses of a more than nominal amount 
under the APM, or be a Medical Home Model expanded under section 
1115A(c) of the Act (81 FR 77408).
    We are maintaining the generally applicable revenue-based nominal 
amount standard at 8 percent for QP Performance Periods 2019 and 2020. 
We are exempting participants in Round 1 of the CPC+ Model as of 
January 1, 2017 from the 50 eligible clinician limit as proposed. We 
are also finalizing a more gradual ramp-up in percentages of revenue 
for the Medical Home Model nominal amount standard over the next 
several years.
c. Qualifying APM Participant (QP) and Partial QP Determinations
    QPs are eligible clinicians in an Advanced APM who have met a 
threshold percentage of their patients or payments through an Advanced 
APM or, beginning in performance year 2019, attain QP status through 
the All-Payer Combination Option. Eligible clinicians who are QPs for a 
year are excluded from the MIPS reporting requirements and payment 
adjustment for the year, and receive a 5 percent APM Incentive Payment 
for the year in years from 2019 through 2024. The statute sets 
thresholds for the level of participation in Advanced APMs required for 
an eligible clinician to become a QP for a year.
    We are finalizing that for Advanced APMs that start or end during 
the QP Performance Period and operate continuously for a minimum of 60 
days during the QP Performance Period for the year, we are making QP 
determinations using payment or patient data only for the dates that 
APM Entities were able to participate in the Advanced APM per the terms 
of the Advanced APM, not for the full QP Performance Period.
    Eligible clinicians who participate in Advanced APMs but do not 
meet the QP or Partial QP thresholds are subject to MIPS reporting 
requirements and payment adjustments unless they are otherwise excluded 
from MIPS.
d. All-Payer Combination Option
    The All-Payer Combination Option, which uses a calculation based on 
an eligible clinician's participation in both Advanced APMs and Other 
Payer Advanced APMs to make QP determinations, is applicable beginning 
in performance year 2019. To become a QP through the All-Payer 
Combination Option, an eligible clinician must participate in an 
Advanced APM with CMS as well as an Other Payer Advanced APM. We 
determine whether other payer arrangements are Other Payer Advanced 
APMs based on information submitted to us by eligible clinicians, APM 
Entities, and in some cases by payers, including states and Medicare 
Advantage Organizations. In addition, the eligible clinician or the APM 
Entity must submit information to CMS so that we can determine whether 
the eligible clinician meets the requisite QP threshold of 
participation.
    To be an Other Payer Advanced APM, as set forth in section 
1833(z)(2)(B)(ii) and (C)(ii) of the Act and implemented in the CY 2017 
Quality Payment Program final rule, a payment arrangement with a payer 
(for example, payment arrangements authorized under Title XIX, Medicare 
Health Plan payment arrangements, and payment arrangements in CMS 
Multi-Payer Models) must meet all three of the following criteria: (1) 
CEHRT is used; (2) the payment arrangement must require the use of 
quality measures comparable to those in the quality performance 
category under MIPS; and (3) the payment arrangement must either 
require the APM Entities to bear more than nominal financial risk if 
actual aggregate expenditures exceed expected aggregate expenditures, 
or be a Medicaid Medical Home Model that meets criteria comparable to 
Medical Home Models expanded under section 1115A(c) of the Act.
    In this final rule with comment period, we are finalizing policies 
that provide more detail about how the All-Payer Combination Option 
will operate. We are finalizing that an other payer arrangement would 
meet the generally applicable revenue-based nominal amount standard we 
proposed if, under the terms of the other payer arrangement, the total 
amount that an APM Entity potentially owes the payer or foregoes is 
equal to at least: For the 2019 and 2020 QP Performance Periods, 8 
percent of the total combined revenues from the payer of providers and 
suppliers in participating APM Entities only for arrangements that are 
expressly defined in terms of revenue. We are also finalizing a more 
gradual ramp-up in percentages of revenue for the Medicaid Medical Home 
Model nominal amount standard over the next several years.
    We are finalizing the Payer Initiated and Eligible Clinician Other 
Payer Advanced APM determination processes to allow payers, APM 
Entities, or eligible clinicians to request that we determine whether 
other payer arrangements meet the Other Payer Advanced APM criteria. We 
have also finalized requirements pertaining to the submission of 
information.
    We are finalizing certain modifications to how we calculate 
Threshold Scores and make QP determinations under the All-Payer 
Combination Option. We are retaining the QP Performance Period for the 
All-Payer Combination Option from January 1 through August 31 of each 
year as finalized in the CY 2017 Quality Payment Program final rule.
e. Physician-Focused Payment Models (PFPMs)
    The PTAC is an 11-member federal advisory committee that is an 
important avenue for the creation of innovative payment models. The 
PTAC is charged with reviewing stakeholders' proposed PFPMs, and making 
comments and recommendations to the Secretary regarding whether they 
meet the PFPM criteria established by the Secretary through rulemaking 
in the CY 2017 Quality Payment Program final rule. The Secretary is 
required to review the comments and recommendations submitted by the 
PTAC and post a detailed response to these recommendations on the CMS 
Web site.
    We sought comments on broadening the definition of PFPM to include 
payment arrangements that involve Medicaid or the Children's Health 
Insurance Program (CHIP) as a payer even if Medicare is not included as 
a payer. We are maintaining the current definition of a PFPM to include 
only payment arrangements with Medicare as a payer. We believe this 
definition retains focus on APMs and Advanced APMs, which would be 
proposals that the Secretary has more direct authority to implement, 
while maintaining consistency for PTAC's review while they are still 
refining their processes. In addition, we sought comment on the 
Secretary's criteria and stakeholders' needs in developing PFPM 
proposals aimed at meeting the criteria.

[[Page 53573]]

4. Summary of Major Provisions for the Merit-Based Incentive Payment 
System (MIPS)
    For Quality Payment Program Year 2, which is the second year of the 
MIPS and includes the 2018 performance period and the 2020 MIPS payment 
year, as well as the following:
a. Quality
    We previously finalized that the quality performance category would 
comprise 60 percent of the final score for the transition year and 50 
percent of the final score for the 2020 MIPS payment year (81 FR 
77100). While we proposed to maintain a 60 percent weight for the 
quality performance category for the 2020 MIPS payment year, we are not 
finalizing this proposal and will be keeping our previously finalized 
policy to weight the quality performance category at 50 percent for the 
2020 MIPS payment year. We are also finalizing that for purposes of the 
2021 MIPS payment year, the performance period for the quality and cost 
performance categories is CY 2019 (January 1, 2019 through December 31, 
2019). We note that we had previously finalized that for the purposes 
of the 2020 MIPS payment year the performance period for the quality 
and cost performance categories is CY 2018 (January 1, 2018 through 
December 31, 2018). We did not make proposals to modify this time frame 
in the CY 2018 Quality Payment Program proposed rule and are therefore 
unable to modify this performance period.
    Quality measures are selected annually through a call for quality 
measures under consideration, with a final list of quality measures 
being published in the Federal Register by November 1 of each year. We 
are finalizing for the CAHPS for MIPS survey for the Quality Payment 
Program Year 2 and future years that the survey administration period 
will, at a minimum, span over 8 weeks and, at a maximum, 17 weeks and 
will end no later than February 28th following the applicable 
performance period. In addition, we are finalizing for the Quality 
Payment Program Year 2 and future years to remove two Summary Survey 
Modules (SSMs), specifically, ``Helping You to Take Medication as 
Directed'' and ``Between Visit Communication'' from the CAHPS for MIPS 
survey.
    For the 2018 MIPS performance period, we previously finalized that 
the data completeness threshold would increase to 60 percent for data 
submitted on quality measures using QCDRs, qualified registries, via 
EHR, or Medicare Part B claims. While we proposed to maintain a 50 
percent data completeness threshold for the 2018 MIPS performance 
period, we are not finalizing this proposal and will be keeping our 
previously finalized data completeness threshold of 60 percent for data 
submitted on quality measures using QCDRs, qualified registries, EHR, 
or Medicare Part B claims for the 2018 MIPS performance period. We also 
proposed to have the data completeness threshold for the 2021 MIPS 
payment year (2019 performance period) to 60 percent for data submitted 
on quality measures using QCDRs, qualified registries, EHR, or Medicare 
Part B claims. We are also finalizing this proposal. We anticipate that 
as MIPS eligible clinicians gain experience with the MIPS we will 
propose to further increase these thresholds over time.
b. Improvement Activities
    Improvement activities are those that improve clinical practice or 
care delivery and that, when effectively executed, are likely to result 
in improved outcomes. We believe improvement activities support broad 
aims within healthcare delivery, including care coordination, 
beneficiary engagement, population management, and health equity. For 
the 2020 MIPS payment year, we previously finalized that the 
improvement activities performance category would comprise 15 percent 
of the final score (81 FR 77179). There are no changes in improvement 
activities scoring for Quality Payment Program Year 2 (2018 MIPS 
performance period) as discussed in section II.C.7.a.(5) of this final 
rule with comment period. However, in this final rule, we are 
finalizing our proposal to no longer require self-identifications for 
non-patient facing MIPS eligible clinicians, small practices, practices 
located in rural areas or geographic HPSAs, or any combination thereof, 
beginning with the 2018 MIPS performance period and for future years.
    We are finalizing that for Quality Payment Program Year 2 and 
future years (2018 MIPS performance period and future years), MIPS 
eligible clinicians or groups must submit data on improvement 
activities in one of the following manners: Via qualified registries, 
EHR submission mechanisms, QCDR, CMS Web Interface, or attestation; and 
that for activities that are performed for at least a continuous 90 
days during the performance period, MIPS eligible clinicians must 
submit a yes response for activities within the Improvement Activities 
Inventory.
    In this final rule with comment period, we are finalizing updates 
to the Improvement Activities Inventory. Specifically, as discussed in 
the appendices (Tables F and G) of this final rule with comment period, 
we are finalizing 21 new improvement activities (some with 
modification) and changes to 27 previously adopted improvement 
activities (some with modification and including 1 removal) for the 
Quality Payment Program Year 2 and future years (2018 MIPS performance 
period and future years) Improvement Activities Inventory. These 
activities were recommended by clinicians, patients and other 
stakeholders interested in advancing quality improvement and 
innovations in healthcare. We will continue to seek new improvement 
activities as the program evolves. Additionally, we are finalizing 
several policies related to submission of improvement activities. In 
particular, we are formalizing the annual call for activities process 
for Quality Payment Program Year 3 and future years. We are finalizing 
with modification, for the Quality Payment Program Year 3 and future 
years, that stakeholders should apply one or more of the criteria when 
submitting improvement activities in response to the Annual Call for 
Activities. In addition to the criteria listed in the proposed rule for 
nominating new improvement activities for the Annual Call for 
Activities policy, we are modifying and expanding the proposed criteria 
list to also include: (1) Improvement activities that focus on 
meaningful actions from the person and family's point of view, and (2) 
improvement activities that support the patient's family or personal 
caregiver. In addition, we are finalizing to: (1) Accept submissions 
for prospective improvement activities at any time during the 
performance period for the Annual Call for Activities and create an 
Improvement Activities Under Review (IAUR) list; (2) only consider 
prospective activities submitted by March 1 for inclusion in the 
Improvement Activities Inventory for the performance periods occurring 
in the following calendar year; and (3) add new improvement activities 
and subcategories through notice-and-comment rulemaking in future years 
of the Quality Payment Program.
    Additionally, we are finalizing that for purposes of the 2021 MIPS 
payment year, the performance period for the improvement activities 
performance category is a minimum of a continuous 90-day period within 
CY 2019, up to and including the full CY 2019 (January 1, 2019 through 
December 31, 2019).
    In this final rule with comment period, we are also expanding our

[[Page 53574]]

definition of how we will recognize an individual MIPS eligible 
clinician or group as being a certified patient-centered medical home 
or comparable specialty practice. We are finalizing our proposal, with 
clarification, that at least 50 percent of the practice sites within 
the TIN must be recognized as a patient-centered medical home or 
comparable specialty practice to receive full credit as a certified or 
recognized patient-centered medical home or comparable specialty 
practice for the 2020 MIPS payment year and future years. We are 
clarifying that a practice site as is the physical location where 
services are delivered. We proposed in section II.C.6.e.(3)(b) of the 
proposed rule (82 FR 30054) that eligible clinicians in practices that 
have been randomized to the control group in the CPC+ model would also 
receive full credit as a Medical Home Model. We are not finalizing this 
proposal, however, because CMMI has not randomized any practices into a 
control group in CPC+ Round 2.
    We are also finalizing changes to the study, including modifying 
the name to the ``CMS Study on Burdens Associated with Reporting 
Quality Measures,'' increasing the sample size for 2018, and updating 
requirements.
    Furthermore, in recognition of improvement activities as supporting 
the central mission of a unified Quality Payment Program, we are 
finalizing in section II.C.6.e.(3)(a) of this final rule with comment 
period to continue to designate activities in the Improvement 
Activities Inventory that will also qualify for the advancing care 
information bonus score. This is consistent with our desire to 
recognize that CEHRT is often deployed to improve care in ways that our 
programs should recognize.
c. Advancing Care Information
    For the Quality Payment Program Year 2, the advancing care 
information performance category is 25 percent of the final score. 
However, if a MIPS eligible clinician is participating in a MIPS APM 
the advancing care information performance category may be 30 percent 
or 75 percent of the final score depending on the availability of APM 
quality data for reporting. We are finalizing that for purposes of the 
2021 MIPS payment year, the performance period for advancing care 
information performance category is a minimum of a continuous 90-day 
period within CY 2019, up to and including the full CY 2019 (January 1, 
2019 through December 31, 2019).
    Objectives and measures in the advancing care information 
performance category focus on the secure exchange of health information 
and the use of CEHRT to support patient engagement and improved 
healthcare quality. While we continue to recommend that physicians and 
clinicians migrate to the implementation and use of EHR technology 
certified to the 2015 Edition so they may take advantage of improved 
functionalities, including care coordination and technical advancements 
such as application programming interfaces, or APIs, we recognize that 
some practices may have challenges in adopting new certified health IT. 
Therefore, we are finalizing that MIPS eligible clinicians may continue 
to use EHR technology certified to the 2014 Edition for the performance 
period in CY 2018. Clinicians may also choose to use the 2015 Edition 
CEHRT or a combination of the two. Clinicians will earn a bonus for 
using only 2015 CEHRT in 2018.
    For the 2018 performance period, MIPS eligible clinicians will have 
the option to report the Advancing Care Information Transition 
Objectives and Measures using 2014 Edition CEHRT, 2015 Edition CEHRT, 
or a combination of 2014 and 2015 Edition CEHRT, as long as the EHR 
technology they possess can support the objectives and measures to 
which they plan to attest. Similarly, MIPS eligible clinicians will 
have the option to attest to the Advancing Care Information Objectives 
and Measures using 2015 Edition CEHRT or a combination of 2014 and 2015 
Edition CEHRT, as long as their EHR technology can support the 
objectives and measures to which they plan to attest.
    We are finalizing exclusions for the e-Prescribing and Health 
Information Exchange Objectives beginning with the 2017 performance 
period. We are also finalizing that eligible clinicians can earn 10 
percentage points in their performance score for reporting to any 
single public health agency or clinical data registry to meet any of 
the measures associated with the Public Health and Clinical Data 
Registry Reporting objective (or any of the measures associated with 
the Public Health Reporting Objective of the 2018 Advancing Care 
Information Transition Objectives and Measures, for clinicians who 
choose to report on those measures) and, and will award an additional 5 
percentage point bonus for reporting to more than one. We are 
implementing several provisions of the 21st Century Cures Act (Pub. L. 
114-255, enacted on December 13, 2016) pertaining to hospital-based 
MIPS eligible clinicians, ambulatory surgical center-based MIPS 
eligible clinicians, MIPS eligible clinicians using decertified EHR 
technology, and significant hardship exceptions under the MIPS. We are 
also finalizing a significant hardship exception for MIPS eligible 
clinicians in small practices. For clinicians requesting a reweighting 
of the advancing care information performance category, we are changing 
the deadline for submission of this application to December 31 of the 
performance period. Lastly, we are finalizing additional improvement 
activities that are eligible for a 10 percent bonus under the advancing 
care information performance category if they are completed using 
CEHRT.
d. Cost
    We previously finalized that the cost performance category would 
comprise zero percent of the final score for the transition year and 10 
percent of the final score for the 2020 MIPS payment year (81 FR 
77165). For the 2020 MIPS payment year, we proposed to change the 
weight of the cost performance category from 10 percent to zero percent 
(82 FR 30047). For the 2020 MIPS payment year, we are finalizing a 10 
percent weight for the cost performance category in the final score in 
order to ease the transition to a 30 percent weight for the cost 
performance category in the 2021 MIPS payment year. For the 2018 MIPS 
performance period, we are adopting the total per capita costs for all 
attributed beneficiaries measure and the Medicare Spending per 
Beneficiary (MSPB) measure that were adopted for the 2017 MIPS 
performance period, and we will not use the 10 episode-based measures 
that were adopted for the 2017 MIPS performance period. Although data 
on the episode-based measures has been made available to clinicians in 
the past, we are in the process of developing new episode-based 
measures with significant clinician input and believe it would be more 
prudent to introduce these new measures over time. We will continue to 
offer performance feedback on episode-based measures prior to potential 
inclusion of these measures in MIPS to increase clinician familiarity 
with the concept as well as specific episode-based measures. 
Specifically, we are providing feedback on these new episode-based cost 
measures for informational purposes only. We intend to provide 
performance feedback on the MSPB and total per capita cost measures by 
July 1, 2018, consistent with section 1848(q)(12) of the Act. In 
addition, we intend to offer feedback on newly developed episode-based 
cost measures in 2018 as well.

[[Page 53575]]

e. Submission Mechanisms
    We are finalizing additional flexibility for submitting data 
through multiple submission mechanisms. Due to operational reasons and 
to allow additional time to communicate how this policy intersects with 
our measure applicability policies, this policy will not be implemented 
for the 2018 performance period but will be implemented instead for the 
2019 performance period of the Quality Payment Program. Individual MIPS 
eligible clinicians or groups will be able to submit measures and 
activities, as available and applicable, via as many mechanisms as 
necessary to meet the requirements of the quality, improvement 
activities, or advancing care information performance categories for 
the 2019 performance period. This option will provide clinicians the 
ability to select the measures most meaningful to them, regardless of 
the submission mechanism.
    Also, given stakeholder concerns regarding CMS' multiple 
submissions mechanism policy, we want to clarify that under the 
validation process for Year 3, MIPS eligible clinicians who submit via 
claims or registry submission only or a combination of claims and 
registry submissions would not be required to submit measures through 
other mechanisms to meet the quality performance category criteria; 
rather, it is an option available to MIPS eligible clinicians which may 
increase their quality performance category score. We expect that MIPS 
eligible clinicians would choose the submission mechanism that would 
give them 6 measures to report. Our intention is to offer multiple 
submission mechanisms to increase flexibility for MIPS individual 
clinicians and groups. We are not requiring that MIPS individual 
clinicians and groups submit via additional submission mechanisms; 
however, through this policy the option would be available for those 
that have applicable measures and/or activities available to them.
f. Virtual Groups
    Virtual groups are a new way to participate in MIPS starting with 
the 2018 MIPS performance period. For the 2018 performance period, 
clinicians can participate in MIPS as an individual, as a group, as an 
APM Entity in a MIPS APM, or as a virtual group.
    For the implementation of virtual groups as a participation option 
under MIPS, we are establishing the following policies. We are defining 
a virtual group as a combination of two or more TINs assigned to one or 
more solo practitioners or one or more groups consisting of 10 or fewer 
eligible clinicians that elect to form a virtual group for a 
performance period for a year. In order for solo practitioners or such 
groups to be eligible to join a virtual group, the solo practitioners 
and the groups would need to exceed the low-volume threshold. A solo 
practitioner or a group that does not exceed the low-volume threshold 
could not participate in a virtual group, and it is not permissible 
under the statute to apply the low-volume threshold at the virtual 
group level. Also, we are finalizing our virtual group policies to 
clearly delineate those group-related policies that apply to virtual 
groups versus policies that only apply to virtual groups.
    Virtual groups are required to make an election to participate in 
MIPS as a virtual group prior to the start of an applicable performance 
period. We are also finalizing a two-stage virtual group election 
process for the applicable 2018 and 2019 performance periods. The first 
stage is the optional eligibility stage, but for practices that do not 
choose to participate in stage 1 of the election process, we will make 
an eligibility determination during stage 2 of the election process. 
The second stage is the virtual group formation stage. We are also 
finalizing that virtual groups must have a formal written agreement 
among each party of a virtual group. The election deadline will be 
December 31.
    To provide support and reduce burden, we intend to make technical 
assistance (TA) available, to the extent feasible and appropriate, to 
support clinicians who choose to come together as a virtual group for 
the first 2 years of virtual group implementation applicable to the 
2018 and 2019 performance years. Clinicians already receiving technical 
assistance may continue to do so for virtual groups support; otherwise, 
the Quality Payment Service Center is available to assist and connect 
virtual groups with a technical assistance representative. For year 2, 
we believe that we have created an election process that is simple and 
straightforward. For Quality Payment Program Year 3, we intend to 
provide an electronic election process, if technically feasible.
    Virtual groups are required to meet the requirements for each 
performance category and responsible for aggregating data for their 
measures and activities across the virtual group, for example, across 
their TINs. In future years, we intend to examine how we define 
``group'' under MIPS with respect to flexibility in composition and 
reporting.
g. MIPS APMs
    MIPS eligible clinicians who participate in MIPS APMs are scored 
using the APM scoring standard instead of the generally applicable MIPS 
scoring standard. For the 2018 performance period, we are finalizing 
modifications to the quality performance category reporting 
requirements and scoring for MIPS eligible clinicians in MIPS APMs, and 
other modifications to the APM scoring standard. For purposes of the 
APM scoring standard, we are adding a fourth snapshot date that would 
be used only to identify eligible clinicians in APM Entity groups 
participating in those MIPS APMs that require full TIN participation. 
This snapshot date will not be used to make QP determinations. Along 
with the other APM Entity groups, these APM Entity groups would be used 
for the purposes of reporting and scoring under the APM scoring 
standard described in the CY 2017 Quality Payment Program final rule 
(81 FR 77246).
h. Facility-Based Measurement
    We solicited comments on implementing facility-based measurement 
for the 2018 MIPS performance period and future performance periods to 
add more flexibility for clinicians to be assessed in the context of 
the facilities at which they work. We described facility-based measures 
policies related to applicable measures, applicability to facility-
based measurement, group participation, and facility attribution. For 
clinicians whose primary professional responsibilities are in a 
healthcare facility we presented a method to assess performance in the 
quality and cost performance categories of MIPS based on the 
performance of that facility in another value-based purchasing program.
    After much consideration, we are finalizing our proposal to allow 
clinicians to use facility-based measurement in year 3 (2019) of the 
Quality Payment Program. We will use the 2018 year to ensure that 
clinicians better understand the opportunity and ensure operational 
readiness to offer facility-based measurement.
i. Scoring
    In the transition year of the Quality Payment Program, we finalized 
a unified scoring system to determine a final score across the 4 
performance categories (81 FR 77273 through 77276). For the 2018 MIPS 
performance period, we will build on the scoring methodology we 
finalized for the transition year, focusing on encouraging

[[Page 53576]]

MIPS eligible clinicians to meet data completeness requirements.
    For quality performance category scoring, we are finalizing to 
extend some of the transition year policies to the 2018 MIPS 
performance period and also finalizing several modifications to 
existing policy. Quality measures that can be scored against a 
benchmark that meet data completeness standards, and meet the minimum 
case size requirements will continue to receive between 3 and 10 points 
as measure achievement points. Measures that do not have a benchmark or 
meet the case minimum requirement will continue to receive 3 points.
    For quality data submitted via EHR, QCDR, or qualified registry, we 
are lowering the number of points available for measures that do not 
meet the data completeness criteria to 1 point, except for a measure 
submitted by a small practice, which we will continue to assign 3 
points.
    We are finalizing a timeline to identify and propose to remove 
topped out quality measures through future rulemaking. We are 
evaluating additional considerations needed to maintain measures for 
important aspects of care, such as patient safety and high reliability, 
and will address this in future rulemaking. We are finalizing a policy 
of applying a scoring cap to identified topped out measures with 
measure benchmarks that have been topped out for at least 2 consecutive 
years; however, based on feedback, we will award up to 7 points for 
topped out measures rather than the 6 points originally proposed. We 
are finalizing the special scoring policy for the 6 measures identified 
for the 2018 performance period with a 7-point scoring cap.
    We are also excluding CMS Web Interface measures from topped out 
scoring, but we will continue to monitor differences between CMS Web 
Interface and other submission options. We intend to address CAHPS 
through future rulemaking.
    Beginning with the 2018 MIPS performance period, we are finalizing 
measuring improvement scoring at the performance category level for the 
quality performance category, but we will monitor this approach and 
revisit as needed through future rule making. We are finalizing 
measuring improvement scoring at the measure level for the cost 
performance category.
    For the 2018 MIPS performance period, the quality, improvement 
activities, cost and advancing care information performance category 
scores will be given weight in the final score, or be reweighted if a 
performance category score is not available.
    We are also finalizing small practice and complex patient bonuses 
only for the 2020 MIPS payment year. The small practice bonus of 5 
points will be applied to the final score for MIPS eligible clinicians 
in groups, virtual groups, or APM Entities that have 15 or fewer 
clinicians and that submit data on at least one performance category in 
the 2018 performance period. We will also apply a complex patient bonus 
capped at 5 points using the dual eligibility ratio and average HCC 
risk score. We increased the complex patients bonus from 3 points as 
proposed in part to align with the small practice bonus. The final 
score will be compared against the MIPS performance threshold of 15 
points for the 2020 MIPS payment year, a modest increase from 3 points 
in the transition year. A 15-point final score equal to the performance 
threshold can be achieved via multiple pathways and continues the 
gradual transition into MIPS. The additional performance threshold for 
exceptional performance will remain at 70 points, the same as for the 
transition year.
    We are finalizing a policy of applying the MIPS payment adjustment 
to the Medicare paid amount.
j. Performance Feedback
    We proposed and are finalizing the policy to provide Quality 
Payment Program performance feedback to eligible clinicians and groups. 
Initially, we will provide performance feedback on an annual basis. In 
future years, we aim to provide performance feedback on a more frequent 
basis, which is in line with clinician requests for timely, actionable 
feedback that they can use to improve care.
k. Third Party Intermediaries
    In the CY 2017 Quality Payment Program final rule (81 FR 77362), we 
finalized that qualified registries, QCDRs, health IT vendors, and CMS-
approved survey vendors will have the ability to act as intermediaries 
on behalf of individual MIPS eligible clinicians and groups for 
submission of data to CMS across the quality, improvement activities, 
and advancing care information performance categories.
    Regarding QCDRs and qualified registries, we are finalizing our 
proposal to eliminate the self-nomination submission method of email 
and require that QCDRs and qualified registries submit their self-
nomination applications via a web-based tool for future program years 
beginning with the 2018 performance period. Beginning with the 2019 
performance period, we are finalizing the use of a simplified self-
nomination process for previously approved QCDRs and qualified 
registries in good standing.
    In addition, regarding information a QCDR specifically must provide 
to us at the time of self-nomination, we are making a number of 
clarifications, finalized that the term ``QCDR measures'' will replace 
the existing term of ``non-MIPS measures'', and sought public input on 
requiring full development and testing of QCDR measures by submission. 
We have also made a few clarifications to existing criteria as they 
pertain to qualified registries.
    We are not making any changes to the health IT vendors that obtain 
data from CEHRT requirements. Regarding CMS-approved survey vendors, we 
are finalizing that for the Quality Payment Program year 2 and for 
future years, that the vendor application deadline be January 31st of 
the applicable performance year or a later date specified by CMS. 
Lastly, based on comments we received on the 10-year record retention 
period and our interest in reducing financial and time burdens under 
this program and having consistent policies across this program, we are 
aligning our record retention period across the program by modifying 
our proposal for third parties from 10 years to finalize a 6-year 
retention period. Therefore, we are finalizing that entities must 
retain all data submitted to us for purposes of MIPS for a 6 years from 
the end of the MIPS performance period.
l. Public Reporting
    As discussed in section II.C.11. of this final rule with comment 
period, we proposed and are finalizing public reporting of certain 
eligible clinician and group Quality Payment Program information, 
including MIPS and APM data in an easily understandable format as 
required under the MACRA.
m. Eligibility and Exclusion Provisions of the MIPS Program
    We are modifying the definition of a non-patient facing MIPS 
eligible clinician to apply to virtual groups. In addition, we are 
finalizing our proposal to specify that groups considered to be non-
patient facing (more than 75 percent of the NPIs billing under the 
group's TIN meet the definition of a non-patient facing individual MIPS 
eligible clinician) during the non-patient facing determination period 
would automatically have their advancing care information performance 
category reweighted to zero.

[[Page 53577]]

    Additionally, we are finalizing our proposal to increase the low-
volume threshold to less than or equal to $90,000 in Medicare Part B 
allowed charges or 200 or fewer Part-B enrolled Medicare beneficiaries 
to further decrease burden on MIPS eligible clinicians that practice in 
rural areas or are part of a small practice or are solo practitioners. 
We are not finalizing our proposal to provide clinicians the ability to 
opt-in to MIPS if they meet or exceed one, but not all, of the low-
volume threshold determinations, including as defined by dollar amount, 
beneficiary count or, if established, items and services. We intend to 
revisit this policy in future rulemaking and are seeking comment on 
methods to implement this policy in a low burden manner.

E. Payment Adjustments

    For the 2020 payment year based on Advanced APM participation in 
2018 performance period, we estimated that approximately 185,000 to 
250,000 clinicians will become QPs, and therefore, be excluded from the 
MIPS reporting requirements and payment adjustment, and qualify for a 
lump sum APM incentive payment equal to 5 percent of their estimated 
aggregate payment amounts for covered professional services in the 
preceding year. We estimate that the total lump sum APM incentive 
payments will be between approximately $675 million and $900 million 
for the 2020 Quality Payment Program payment year. This expected growth 
in QPs between the first and second year of the program is due in part 
to reopening of CPC+ and Next Generation ACO for 2018, and the Medicare 
ACO Track 1+ Model which is projected to have a large number of 
participants, with a large majority reaching QP status.
    Under the policies in this final rule with comment period, and for 
purposes of the Regulatory Impact Analysis, we estimate that 
approximately 622,000 eligible clinicians will be subject to MIPS 
reporting requirements and payment adjustments in the 2018 MIPS 
performance period. However, this number may vary depending on the 
number of eligible clinicians excluded from MIPS based on their status 
as QPs or Partial QPs. After restricting the population to eligible 
clinician types who are not newly enrolled, we believe the increase in 
the low-volume threshold is expected to exclude 540,000 clinicians who 
do not exceed the low-volume threshold. In the 2020 MIPS payment year, 
MIPS payment adjustments will be applied based on MIPS eligible 
clinicians' performance on specified measures and activities within 
four integrated performance categories.
    Assuming that 90 percent of MIPS eligible clinicians of all 
practice sizes participate in MIPS, we estimate that MIPS payment 
adjustments will be approximately equally distributed between negative 
MIPS payment adjustments of $118 million and positive MIPS payment 
adjustments of $118 million to MIPS eligible clinicians, as required by 
the statute to ensure budget neutrality. Positive MIPS payment 
adjustments will also include up to an additional $500 million for 
exceptional performance to MIPS eligible clinicians whose final score 
meets or exceeds the additional performance threshold of 70 points. 
These MIPS payment adjustments are expected to drive quality 
improvement in the provision of MIPS eligible clinicians' care to 
Medicare beneficiaries and to all patients in the health care system. 
However, the distribution will change based on the final population of 
MIPS eligible clinicians for CY 2020 and the distribution of scores 
under the program. We believe that starting with these modest initial 
MIPS payment adjustments is in the long-term best interest of 
maximizing participation and starting the Quality Payment Program off 
on the right foot, even if it limits the magnitude of MIPS positive 
adjustments during the 2018 MIPS performance period. The increased 
availability of Advanced APM opportunities, including through Medical 
Home models, also provides earlier avenues to earn APM incentive 
payments for those eligible clinicians who choose to participate.

F. Benefits and Costs of the Final Rule With Comment Period

    We quantify several costs associated with this rule. We estimate 
that this final rule with comment period will result in approximately 
$694 million in collection of information-related burden. We estimate 
that the incremental collection of information-related burden 
associated with this final rule with comment period is a reduction of 
approximately $13.9 million relative to the estimated burden of 
continuing the policies the CY 2017 Quality Payment Program final rule, 
which is $708 million. We also estimate regulatory review costs of $2.2 
million for this final rule with comment period. We estimate that 
federal expenditures will include $118 million in revenue neutral 
payment adjustments and $500 million for exceptional performance 
payments. Additional federal expenditures include approximately $675-
$900 million in APM incentive payments to QPs.

G. Automatic Extreme and Uncontrollable Circumstance Policy Interim 
Final Rule With Comment Period

    In order to account for Hurricanes Harvey, Irma, and Maria and 
other disasters that have occurred or might occur during the 2017 MIPS 
performance period, we are establishing in an interim final rule with 
comment period an automatic extreme and uncontrollable circumstance 
policy for the quality, improvement activities, and advancing care 
information performance categories for the 2017 MIPS performance 
period. We believe the automatic extreme and uncontrollable 
circumstance policy will reduce clinician burden during a catastrophic 
time and will also align with Medicare policies in other programs such 
as the Hospital IQR Program. Under this policy, we will apply the 
extreme and uncontrollable circumstance policies for the MIPS 
performance categories to individual MIPS eligible clinicians for the 
2017 MIPS performance period without requiring a MIPS eligible 
clinician to submit an application when we determine a triggering 
event, such as a hurricane, has occurred and the clinician is in an 
affected area. We will automatically weight the quality, improvement 
activities, and advancing care information performance categories at 
zero percent of the final score, resulting in a final score equal to 
the performance threshold, unless the MIPS eligible clinician submits 
MIPS data which we would then score on a performance-category-by-
performance-category-basis, like all other MIPS eligible clinicians. We 
are not making any changes to the APM scoring standard policies that 
apply in 2017 for participants in MIPS APMs. We are waiving notice and 
comment and adopting this policy on an interim final basis due to the 
urgency of providing relief for MIPS eligible clinicians impacted by 
recent natural disasters during the 2017 MIPS performance period.

H. Stakeholder Input

    In developing this final rule with comment period, we sought 
feedback from stakeholders and the public throughout the process, 
including in the CY 2018 Quality Payment Program proposed rule, CY 2017 
Quality Payment Program final rule with comment period, listening 
sessions, webinars, and other listening venues. We received a high 
degree of interest

[[Page 53578]]

from a broad spectrum of stakeholders. We thank our many commenters and 
acknowledge their valued input throughout the rulemaking process. We 
summarize and respond to comments on our proposals in the appropriate 
sections of this final rule with comment period, though we are not able 
to address all comments or all issues that all commenters raised due to 
the volume of comments and feedback. Specifically, due to the volume of 
comments we have not summarized feedback from commenters on items we 
solicited feedback on for future rulemaking purposes. However, in 
general, commenters continue to be supportive as we continue 
implementation of the Quality Payment Program and maintain optimism as 
we move from FFS Medicare payment towards a payment structure focused 
on the quality and value of care. Public support for our proposed 
approach and policies in the proposed rule, which many were finalized, 
focused on the potential for improving the quality of care delivered to 
beneficiaries and increasing value to the public--while rewarding 
eligible clinicians for their efforts. Additionally we note that we 
received a number of comments from stakeholders in regards to the 
application of MIPS to certain Part B drugs. Additional guidance on the 
applicability of MIPS to Part B drugs can be found on our Web site at 
qpp.cms.gov.
    We thank stakeholders again for their responses throughout our 
process, in various venues, including comments on the Request for 
Information Regarding Implementation of the Merit-based Incentive 
Payment System, Promotion of Alternative Payment Models, and Incentive 
Payments for Participation in Eligible Alternative Payment Models 
(herein referred to as the MIPS and APMs RFI) (80 FR 59102 through 
59113) and the CY 2017 Quality Payment Program final rule (81 FR 77008 
through 77831). We intend to continue open communication with 
stakeholders, including consultation with tribes and tribal officials, 
on an ongoing basis as we develop the Quality Payment Program in future 
years.
    We will continue to offer help so clinicians can be successful in 
the program and make informed decisions about how to participate. You 
can find out more about the help that's available at qpp.cms.gov, which 
has many free and customized resources, or by calling 1-866-288-8292. 
As with the policy decisions, stakeholder feedback is essential to the 
development of educational resources as well. We look forward to your 
feedback on existing or the need for new resources.

II. Provisions of the Proposed Regulations, and Analysis of and 
Responses to Comments

    The following is a summary of the proposed provisions in the 
``Medicare Program; CY 2018 Updates to the Quality Payment Program'' 
proposed rule (82 FR 30010-30500) (hereinafter referred to as the ``CY 
2018 Quality Payment Program proposed rule.'' In this section, we also 
provide summaries of the public comments and our responses.

A. Introduction

    The Quality Payment Program, authorized by the Medicare Access and 
CHIP Reauthorization Act of 2015 (MACRA) is a new approach for 
reforming care across the health care delivery system for eligible 
clinicians. Under the Quality Payment Program, eligible clinicians can 
participate via one of two pathways: Advanced Alternative Payment 
Models (APMs); or the Merit-based Incentive Payment System (MIPS). We 
began implementing the Quality Payment Program through rulemaking for 
calendar year (CY) 2017. This rule provides updates for the second and 
future years of the Quality Payment Program.

B. Definitions

    At Sec.  414.1305, subpart O, we define the following terms:

 Ambulatory Surgical Center (ASC)-based MIPS eligible 
clinician.
 CMS Multi-Payer Model.
 Facility-based MIPS eligible clinician.
 Full TIN APM.
 Improvement Scoring.
 Other MIPS APM.
 Solo practitioner.
 Virtual group.

    We revise the definitions of the following terms:

 Affiliated practitioner.
 APM Entity.
 Attributed beneficiary.
 Certified Electronic Health Record Technology (CEHRT).
 Final Score.
 Hospital-based MIPS eligible clinician.
 Low-volume threshold.
 Medicaid APM.
 Non-patient facing MIPS eligible clinician.
 Other Payer Advanced APM.
 Rural areas.
 Small practice.

    We remove the following terms:

 Advanced APM Entity.

    These terms and definitions are discussed in detail in relevant 
sections of this final rule with comment period.

C. MIPS Program Details

1. MIPS Eligible Clinicians
a. Definition of a MIPS Eligible Clinician
    In the CY 2017 Quality Payment Program final rule (81 FR77040 
through 77041), we defined at Sec.  414.1305 a MIPS eligible clinician, 
as identified by a unique billing TIN and NPI combination used to 
assess performance, as any of the following (excluding those identified 
at Sec.  414.1310(b)): A physician (as defined in section 1861(r) of 
the Act), a physician assistant, nurse practitioner, and clinical nurse 
specialist (as such terms are defined in section 1861(aa)(5) of the 
Act), a certified registered nurse anesthetist (as defined in section 
1861(bb)(2) of the Act), and a group that includes such clinicians. We 
established at Sec.  414.1310(b) and (c) that the following are 
excluded from this definition per the statutory exclusions defined in 
section 1848(q)(1)(C)(ii) and (v) of the Act: (1) QPs; (2) Partial QPs 
who choose not to report on applicable measures and activities that are 
required to be reported under MIPS for any given performance period in 
a year; (3) low-volume threshold eligible clinicians; and (4) new 
Medicare-enrolled eligible clinicians. In accordance with sections 
1848(q)(1)(A) and (q)(1)(C)(vi) of the Act, we established at Sec.  
414.1310(b)(2) that eligible clinicians (as defined at Sec.  414.1305) 
who are not MIPS eligible clinicians have the option to voluntarily 
report measures and activities for MIPS. Additionally, we established 
at Sec.  414.1310(d) that in no case will a MIPS payment adjustment 
apply to the items and services furnished during a year by eligible 
clinicians who are not MIPS eligible clinicians, as described in Sec.  
414.1310(b) and (c), including those who voluntarily report on 
applicable measures and activities specified under MIPS.
    In the CY 2017 Quality Payment Program final rule (81 FR 77340), we 
noted that the MIPS payment adjustment applies only to the amount 
otherwise paid under Part B with respect to items and services 
furnished by a MIPS eligible clinician during a year, in which we will 
apply the MIPS payment adjustment at the TIN/NPI level. We have 
received requests for additional clarifications on which specific Part 
B services are subject to the MIPS payment adjustment, as well as which 
Part B services are included for eligibility determinations. We note 
that

[[Page 53579]]

when Part B items or services are furnished by suppliers that are also 
MIPS eligible clinicians, there may be circumstances in which it is not 
operationally feasible for us to attribute those items or services to a 
MIPS eligible clinician at an NPI level in order to include them for 
purposes of applying the MIPS payment adjustment or making eligibility 
determinations.
    To further clarify, there are circumstances that involve Part B 
prescription drugs and durable medical equipment (DME) where the 
supplier may also be a MIPS eligible clinician. In the case of a MIPS 
eligible clinician who furnishes a Part B covered item or service, such 
as prescribing Part B drugs that are dispensed, administered, and 
billed by a supplier that is a MIPS eligible clinician, or ordering DME 
that is administered and billed by a supplier that is a MIPS eligible 
clinician, it is not operationally feasible for us at this time to 
associate those billed allowed charges with a MIPS eligible clinician 
at an NPI level in order to include them for purposes of applying the 
MIPS payment adjustment or making eligibility determinations. To the 
extent that it is not operationally feasible for us to do so, such 
items or services would not be included for purposes of applying the 
MIPS payment adjustment or making eligibility determinations. However, 
for those billed Medicare Part B allowed charges that we are able to 
associate with a MIPS eligible clinician at an NPI level, such items 
and services would be included for purposes of applying the MIPS 
payment adjustment or making eligibility determinations.
b. Groups
    As discussed in the CY 2017 Quality Payment Program final rule (81 
FR 77088 through 77831), we indicated that we will assess performance 
either for individual MIPS eligible clinicians or for groups. We 
defined a group at Sec.  414.1305 as a single Taxpayer Identification 
Number (TIN) with two or more eligible clinicians (including at least 
one MIPS eligible clinician), as identified by their individual NPI, 
who have reassigned their Medicare billing rights to the TIN. We 
recognize that MIPS eligible clinicians participating in MIPS may be 
part of a TIN that has one portion of its NPIs participating in MIPS 
according to the generally applicable scoring criteria while the 
remaining portion of its NPIs is participating in a MIPS APM or an 
Advanced APM according to the MIPS APM scoring standard. In the CY 2017 
Quality Payment Program final rule (81 FR 77058), we noted that except 
for groups containing APM participants, we are not permitting groups to 
``split'' TINs if they choose to participate in MIPS as a group. Thus, 
we would like to clarify that we consider a group to be either an 
entire single TIN or portion of a TIN that: (1) Is participating in 
MIPS according to the generally applicable scoring criteria while the 
remaining portion of the TIN is participating in a MIPS APM or an 
Advanced APM according to the MIPS APM scoring standard; and (2) 
chooses to participate in MIPS at the group level. We also defined an 
APM Entity group at Sec.  414.1305 as a group of eligible clinicians 
participating in an APM Entity, as identified by a combination of the 
APM identifier, APM Entity identifier, TIN, and NPI for each 
participating eligible clinician.
c. Small Practices
    In the CY 2017 Quality Payment Program final rule (81 FR 77188), we 
defined the term small practices at Sec.  414.1305 as practices 
consisting of 15 or fewer clinicians and solo practitioners. However, 
it has come to our attention that there is inconsistency between the 
proposed definition of a solo practitioner discussed in section 
II.C.4.b. of this final rule with comment period and the established 
definition of a small practice. Therefore, to resolve this 
inconsistency and ensure greater consistency with established MIPS 
terminology, we are modifying the definition of a small practice at 
Sec.  414.1305 to mean a practice consisting of 15 or fewer eligible 
clinicians. This modification is not intended to substantively change 
the definition of a small practice. In section II.C.4.d. of this final 
rule with comment period, we discuss how small practice status would 
apply to virtual groups. Also, in the final rule with comment period, 
we noted that we would not make an eligibility determination regarding 
the size of small practices, but indicated that small practices would 
attest to the size of their group practice (81 FR 77057). However, we 
have since realized that our system needs to account for small practice 
size in advance of a performance period for operational purposes 
relating to assessing and scoring the improvement activities 
performance category, determining hardship exceptions for small 
practices, calculating the small practice bonus for the final score, 
and identifying small practices eligible for technical assistance. As a 
result, we believe it is critical to modify the way in which small 
practice size would be determined. To make eligibility determinations 
regarding the size of small practices for performance periods occurring 
in 2018 and future years, we proposed that we would determine the size 
of small practices as described in this section of the final rule with 
comment period (82 FR 30020). As noted in the CY 2017 Quality Payment 
Program final rule, the size of a group (including a small practice) 
would be determined before exclusions are applied (81 FR 77057). We 
note that group size determinations are based on the number of NPIs 
associated with a TIN, which would include eligible clinicians (NPIs) 
who may be excluded from MIPS participation and do not meet the 
definition of a MIPS eligible clinician.
    To make eligibility determinations regarding the size of small 
practices for performance periods occurring in 2018 and future years, 
we proposed that we would determine the size of small practices by 
utilizing claims data (82 FR 30020). For purposes of this section, we 
are coining the term ``small practice size determination period'' to 
mean a 12-month assessment period, which consists of an analysis of 
claims data that spans from the last 4 months of a calendar year 2 
years prior to the performance period followed by the first 8 months of 
the next calendar year and includes a 30-day claims run out. This would 
allow us to inform small practices of their status near the beginning 
of the performance period as it pertains to eligibility relating to 
technical assistance, applicable improvement activities criteria, the 
proposed hardship exception for small practices under the advancing 
care information performance category, and the proposed small practice 
bonus for the final score.
    Thus, for purposes of performance periods occurring in 2018 and the 
2020 MIPS payment year, we would identify small practices based on 12 
months of data starting from September 1, 2016 to August 31, 2017. We 
would not change an eligibility determination regarding the size of a 
small practice once the determination is made for a given performance 
period and MIPS payment year. We recognize that there may be 
circumstances in which the small practice size determinations made do 
not reflect the real-time size of such practices. We considered two 
options that could address such potential discrepancies. One option 
would include an expansion of the proposed small practice size 
determination period to 24 months with two 12-month segments of data 
analysis (before and during the performance period), in which we would 
conduct a second analysis of claims data during the performance period. 
Such an expanded

[[Page 53580]]

determination period may better capture the real-time size of small 
practices, but determinations made during the performance period 
prevent our system from being able to account for the assessment and 
scoring of the improvement activities performance category and 
identification of small practices eligible for technical assistance 
prior to the performance period. Specifically, our system needs to 
capture small practice determinations in advance of the performance 
period in order for the system to reflect the applicable requirements 
for the improvement activities performance category and when a small 
practice bonus would be applied. A second option would include an 
attestation component, in which a small practice that was not 
identified as a small practice during the small practice size 
determination period would be able to attest to the size of their group 
practice prior to the performance period. However, this second option 
would require us to develop several operational improvements, such as a 
manual process or system that would provide an attestation mechanism 
for small practices, and a verification process to ensure that only 
small practices are identified as eligible for technical assistance. 
Since individual MIPS eligible clinicians and groups are not required 
to register to participate in MIPS (except for groups utilizing the CMS 
Web Interface for the Quality Payment Program or administering the 
CAHPS for MIPS survey), requiring small practices to attest to the size 
of their group practice prior to the performance period could increase 
burden on individual MIPS eligible clinicians and groups that are not 
already utilizing the CMS Web Interface for the Quality Payment Program 
or administering the CAHPS for MIPS survey. We solicited public comment 
on the proposal regarding how we would determine small practice size.
    The following is a summary of the public comments received on the 
``Small Practices'' proposal and our responses:
    Comment: Several commenters supported using historical claims data 
to make a small practice size determination. One commenter also noted 
support for the definition of a small practice using the number of NPIs 
associated with a TIN.
    Response: We are finalizing that we will utilize a 12-month 
assessment period, which consists of an analysis of claims data that 
spans from the last 4 months of a calendar year 2 years prior to the 
performance period followed by the first 8 months of the next calendar 
year and includes a 30-day claims run out for the small practice size 
determination.
    Comment: Several commenters supported the proposal to notify small 
practices of their status near the beginning of the performance period 
so that practices can plan accordingly.
    Response: We are finalizing that we will utilize a 12-month 
assessment period, which consists of an analysis of claims data that 
spans from the last 4 months of a calendar year 2 years prior to the 
performance period followed by the first 8 months of the next calendar 
year and includes a 30-day claims run out for the small practice size 
determination. We anticipate providing MIPS eligible clinicians with 
their small practice size determination by Spring 2018, for the 
applicable 2018 performance period.
    Comment: Several commenters recommended that practices be allowed 
to attest the size of their practice if they are not identified during 
the small practice size determination period. Specifically, a few 
commenters expressed concern that utilizing claims data will result in 
practices learning of their small practice status too close to the 
start of the performance period. A few commenters recommended that we 
should rely on attestation alone, and expressed concern that claims 
data will not provide a reliable, real-time determination of practice 
size. Another commenter specifically recommended that practices be 
required to attest 180 days before the close of the performance period 
so that practices can accurately predict their status. One commenter 
recommended that we validate practice size for groups attesting as 
small using recent claims data. One commenter recommended utilizing a 
claims determination process as well as attestation, and using 
whichever method yields a smaller practice size.
    Response: Regarding the various commenters that provided different 
methods for validating practice size, including: Attesting as small 
using recent claims data; utilizing an 180 days attestation period; or 
utilizing a claims determination process as well as attestation, we 
have considered various approaches and have determined that the most 
straightforward approach which provides the lowest burden to MIPS 
eligible clinicians is the utilization of claims data. By utilizing 
claims data, we can apply the status of a small practice accurately 
without requiring clinicians to take a separate action and attest to 
being a small practice. Therefore, we are finalizing that we will 
utilize a 12-month assessment period, which consists of an analysis of 
claims data that spans from the last 4 months of a calendar year 2 
years prior to the performance period followed by the first 8 months of 
the next calendar year and includes a 30-day claims run out for the 
small practice size determination. We anticipate providing MIPS 
eligible clinicians with their small practice size determination by 
Spring 2018, for the applicable 2018 performance period.
    As discussed in the CY 2018 Quality Payment Program proposed rule 
(82 FR 30020), there are operational barriers with allowing groups to 
attest to their size. Specifically, since individual MIPS eligible 
clinicians and groups are not required to register to participate in 
MIPS (except for groups utilizing the CMS Web Interface for the Quality 
Payment Program or administering the CAHPS for MIPS survey), requiring 
small practices to attest to the size of their group practice prior to 
the performance period could increase burden on individual MIPS 
eligible clinicians and groups. In addition, attestation would require 
us to develop several operational improvements, such as a manual 
process or system that would provide an attestation mechanism for small 
practices, and a verification process to ensure that only small 
practices are identified as eligible for technical assistance. We 
believe utilizing claims data will support most eligibility 
determinations because we consider it a reliable source of how a MIPS 
eligible clinician or group interacts with Medicare.
    Comment: One commenter expressed concern that using performance 
period data or an attestation portal as a second step in the small 
practice identification process does not provide practices with 
adequate advanced notice of their practice size determination and could 
limit their ability to access small practice support services.
    Response: We are finalizing that we will utilize a 12-month 
assessment period, which consists of an analysis of claims data that 
spans from the last 4 months of a calendar year 2 years prior to the 
performance period followed by the first 8 months of the next calendar 
year and includes a 30-day claims run out for the small practice size 
determination. This proposed modification of the claims run out period 
from 60 days to 30 days increases the speed of delivery for 
communication and creation of the file using claims data. In addition, 
using the 30-day claims run out allows us to inform small practices of 
their determination as soon as technically possible, as it pertains to 
eligibility relating to technical assistance, applicable improvement

[[Page 53581]]

activities criteria, the proposed hardship exception for small 
practices under the advancing care information performance category, 
and the proposed small practice bonus for the final score. As a result, 
we do not believe clinicians' ability to access small practice support 
services will be limited.
    Comment: A few commenters recommended that we should not allow 
practices to attest that they are small practices. Specifically, one 
commenter expressed concern that practices may mistakenly expect to be 
identified as small based on their number of MIPS eligible clinicians 
and attest incorrectly.
    Response: We acknowledge and agree with the commenters' concern. We 
have considered various approaches and have determined that the most 
straightforward and best representation of small practice size 
determination is the utilization of claims data. Therefore, we are 
finalizing that we will utilize a 12-month assessment period, which 
consists of an analysis of claims data that spans from the last 4 
months of a calendar year 2 years prior to the performance period 
followed by the first 8 months of the next calendar year and includes a 
30-day claims run out for the small practice size determination.
    Comment: Several commenters did not support the previously 
finalized definition of small practices as practices consisting of 15 
or fewer clinicians and solo practitioners. One commenter recommended 
that we modify the definition of small practices to include those that 
are similar in challenges and structure, but that may include more than 
15 clinicians. The commenter noted that several small practices may be 
loosely tied together under the same TIN but may function as small 
practices without the benefit of shared organizational and 
administrative resources. The commenter recommended that we assess the 
number of clinicians at a physical practice site to determine small 
practice status and ability to join a virtual group. Several commenters 
believed that we should define small practices based on the number of 
MIPS eligible clinicians, not eligible clinicians. A few commenters 
supported defining small practices based on the number of full-time 
equivalent employees, arguing that rural and HPSAs use different 
staffing arrangements to fully staff their practices.
    Response: Section 1848(q)(2)(B)(iii) of the Act defines small 
practices as consisting of 15 or fewer professionals. We previously 
defined small practices at Sec.  414.1305 as practices consisting of 15 
or fewer clinicians and solo practitioners in order to include both 
MIPS eligible clinicians and eligible clinicians, such as those in 
APMs. As discussed above, we are modifying the definition of a small 
practice at Sec.  414.1305 to mean a practice consisting of 15 or fewer 
eligible clinicians. This modification is not intended to substantively 
change the definition of a small practice. In response to the 
suggestions that we assess the number of clinicians at a physical 
practice site to determine small practice status, or make the small 
practice assessment based on the number of full-time equivalent 
employees, we acknowledge that some practices may be structured in this 
manner; however, we do not currently have a reliable method of making a 
determination that does not require a separate action from such 
practices, such as attestation or submission of supporting 
documentation to verify these statuses. Rather, we believe the approach 
of simply counting the NPIs (clinicians) that are associated with a TIN 
provides a simple method for all stakeholders to understand.
    Final Action: After consideration of the public comments, we are 
finalizing that we will utilize a 12-month assessment period, which 
consists of an analysis of claims data that spans from the last 4 
months of a calendar year 2 years prior to the performance period 
followed by the first 8 months of the next calendar year and includes a 
30-day claims run out for the small practice size determination. In 
addition, as discussed above, we are modifying the definition of a 
small practice at Sec.  414.1305 to mean a practice consisting of 15 or 
fewer eligible clinicians. This modification is not intended to 
substantively change the definition of a small practice. Finally, we 
refer readers to section II.C.4.b. of this final rule with comment 
period for a discussion of the definition of a solo practitioner.
d. Rural Area and Health Professional Shortage Area Practices
    In the CY 2017 Quality Payment Program final rule, we defined rural 
areas at Sec.  414.1305 as clinicians in ZIP codes designated as rural, 
using the most recent Health Resources and Services Administration 
(HRSA) Area Health Resource File data set available; and Health 
Professional Shortage Areas (HPSAs) at Sec.  414.1305 as areas 
designated under section 332(a)(1)(A) of the Public Health Service Act. 
For technical accuracy purposes, we proposed to remove the language 
``clinicians in'' as clinicians are not technically part of a ZIP code 
and modify the definition of a rural areas at Sec.  414.1305 as ZIP 
codes designated as rural, using the most recent Health Resources and 
Services Administration (HRSA) Area Health Resource File data set 
available.
    We recognize that there are cases in which an individual MIPS 
eligible clinician (including a solo practitioner) or a group may have 
multiple practice sites associated with its TIN and as a result, it is 
critical for us to outline the application of rural area and HPSA 
practice designations to such practices. For performance periods 
occurring in 2017, we consider an individual MIPS eligible clinician or 
a group with at least one practice site under its TIN in a ZIP code 
designated as a rural area or HPSA to be a rural area or HPSA practice. 
For performance periods occurring in 2018 and future years, we believe 
that a higher threshold than one practice within a TIN is necessary to 
designate an individual MIPS eligible clinician, a group, or a virtual 
group as a rural or HPSA practice. We recognize that the establishment 
of a higher threshold starting in 2018 would more appropriately 
identify groups and virtual groups with multiple practices under a 
group's TIN or TINs that are part of a virtual group as rural or HPSA 
practice and ensure that groups and virtual groups are assessed and 
scored according to requirements that are applicable and appropriate. 
We note that in the CY 2017 Quality Payment Program final rule (81 FR 
77048 through 77049), we defined a non-patient facing MIPS eligible 
clinician at Sec.  414.1305 as including a group provided that more 
than 75 percent of the NPIs billing under the group's TIN meet the 
definition of a non-patient facing individual MIPS eligible clinician 
during the non-patient facing determination period. We refer readers to 
section II.C.1.e. of this final rule with comment period for our policy 
to modify the definition of a non-patient facing MIPS eligible 
clinician. We believe that using a similar threshold for applying the 
rural and HPSA designation to an individual MIPS eligible clinician, a 
group, or virtual group with multiple practices under its TIN or TINs 
within a virtual group will add consistency for such practices across 
the MIPS as it pertains to groups and virtual groups obtaining such 
statuses. We also believe that establishing a 75 percent threshold 
renders an adequate representation of a group or virtual group where a 
significant portion of a group or a virtual group is identified as 
having such status. Therefore, for performance periods occurring in 
2018 and future years, we proposed that an individual

[[Page 53582]]

MIPS eligible clinician, a group, or a virtual group with multiple 
practices under its TIN or TINs within a virtual group would be 
designated as a rural or HPSA practice if more than 75 percent of NPIs 
billing under the individual MIPS eligible clinician or group's TIN or 
within a virtual group, as applicable, are designated in a ZIP code as 
a rural area or HPSA (82 FR 30020 through 30021).
    The following is a summary of the public comments received on the 
``Rural Area and Health Professional Shortage Area Practices'' 
proposals and our responses:
    Comment: Several commenters supported the proposals to modify the 
definition of rural areas as ZIP codes designated as rural and a rural 
group when more than 75 percent of NPIs billing under the individual 
MIPS eligible clinician or group's TIN or within a virtual group, as 
applicable, are designated in a ZIP code as a rural area or HPSA. 
Another commenter recommended that we conduct further analysis on those 
clinicians who thought they qualified as a rural area or HPSA practice 
but did not meet the 75 percent threshold.
    Response: We are finalizing that the definition of a rural areas at 
Sec.  414.1305 as ZIP codes designated as rural, using the most recent 
Health Resources and Services Administration (HRSA) Area Health 
Resource File data set available. In addition, we are finalizing that 
for performance periods occurring in 2018 and future years, that an 
individual MIPS eligible clinician, a group, or a virtual group with 
multiple practices under its TIN or TINs within a virtual group would 
be designated as a rural or HPSA practice if more than 75 percent of 
NPIs billing under the individual MIPS eligible clinician or group's 
TIN or within a virtual group, as applicable, are designated in a ZIP 
code as a rural area or HPSA. In regard to the suggestion that we 
conduct further analysis on those clinicians who thought they qualified 
as a rural area or HPSA practice but did not meet the 75 percent 
threshold, we would encourage those stakeholders to contact our Quality 
Payment Program Service Center which may be reached at 1-866-288-8292 
(TTY 1-877-715-6222), available Monday through Friday, 8:00 a.m.-8:00 
p.m. Eastern Time or via email at [email protected].
    Comment: One commenter recommended we further analyze the 
characteristics of practices currently defined as rural or HPSA to 
identify practices that may be inappropriately classified.
    Response: We believe that establishing a 75 percent threshold more 
appropriately identifies groups and virtual groups with multiple 
practices under a group's TIN or TINs that are part of a virtual group 
as rural or HPSA practices and ensure that groups and virtual groups 
are assessed and scored according to requirements that are applicable 
and appropriate. We will take the suggestions for further analysis on 
the characteristics of practices currently defined as rural or HPSA to 
identify practices that may be inappropriately classified into 
consideration in future rulemaking as necessary.
    Comment: Several commenters did not support the proposed definition 
of rural areas and did not support the proposed group definition of 
rural and HPSA practice. One commenter did not support the use of ZIP 
codes as a reliable indicator of rural status as some clinicians have 
multiple sites inside and outside of rural areas. A few commenters 
recommended that we not adopt the policy that a group be considered 
rural if more than 75 percent of NPIs billing under the TIN are 
designated in a ZIP code as rural or HPSA because it would overly limit 
the number of rural group practices. Of these commenters, two 
recommended using 50 percent as a threshold, and one commenter 
recommended a gradual transition using the 2017 threshold for the 2018 
MIPS performance period and thresholds of 25 percent, 50 percent, and 
75 percent in performance periods occurring in 2019, 2020, and 2021, 
respectively. A few commenters believed that expanding the number of 
clinicians in rural or HPSA groups would hamper the ability of those 
practices to participate fully in the transition to value-based care 
and increase disparities between urban and rural care. One commenter 
stated that the status of rural or HPSA should be assigned to an 
individual but not be assigned to a group.
    Response: We are finalizing that an individual MIPS eligible 
clinician, a group, or a virtual group with multiple practices under 
its TIN or TINs within a virtual group would be designated as a rural 
or HPSA practice if more than 75 percent of NPIs billing under the 
individual MIPS eligible clinician or group's TIN or within a virtual 
group, as applicable, are designated in a ZIP code as a rural area or 
HPSA. We do not believe establishing a 75 percent threshold would 
overly limit the number of rural group practices, nor hamper their 
ability to participate fully in the transition to value-based care, or 
increase disparities between urban and rural care. In response to the 
various threshold recommendations, we believe that the 75 percent 
threshold provides adequate representation of the group, and it also 
aligns with our definition of a non-patient facing group, which 
provides consistency across the program. We believe rural and HPSA 
status should be assigned to groups because we believe those clinicians 
that are in a rural or HPSA area and choose to participate in MIPS as 
part of a group, should receive the benefit of those statuses, 
regardless of their chosen participation mechanism. In regards to the 
commenter who did not support the use of ZIP codes as a reliable 
indicator of rural status due to clinicians practicing at multiple 
sites, we disagree. We believe that utilizing ZIP codes designated as 
rural is an appropriate indicator of rural status. We further note that 
if a clinician practices at multiple sites that have different TINs, 
each TIN would have a separate rural analysis applied for that 
particular site (TIN).
    Final Action: After consideration of the public comments, we are 
finalizing the definition of rural areas at Sec.  414.1305 as ZIP codes 
designated as rural, using the most recent Health Resources and 
Services Administration (HRSA) Area Health Resource File data set 
available. In addition, we are finalizing that for performance periods 
occurring in 2018 and future years, that an individual MIPS eligible 
clinician, a group, or a virtual group with multiple practices under 
its TIN or TINs within a virtual group would be designated as a rural 
or HPSA practice if more than 75 percent of NPIs billing under the 
individual MIPS eligible clinician or group's TIN or within a virtual 
group, as applicable, are designated in a ZIP code as a rural area or 
HPSA.
e. Non-Patient Facing MIPS Eligible Clinicians
    Section 1848(q)(2)(C)(iv) of the Act requires the Secretary, in 
specifying measures and activities for a performance category, to give 
consideration to the circumstances of professional types (or 
subcategories of those types determined by practice characteristics) 
who typically furnish services that do not involve face-to-face 
interaction with a patient. To the extent feasible and appropriate, the 
Secretary may take those circumstances into account and apply 
alternative measures or activities that fulfill the goals of the 
applicable performance category to such non-patient facing MIPS 
eligible clinicians. In carrying out these provisions, we are required 
to consult with non-patient facing MIPS eligible clinicians.
    In addition, section 1848(q)(5)(F) of the Act allows the Secretary 
to re-weight

[[Page 53583]]

MIPS performance categories if there are not sufficient measures and 
activities applicable and available to each type of MIPS eligible 
clinician. We assume many non-patient facing MIPS eligible clinicians 
will not have sufficient measures and activities applicable and 
available to report under the performance categories under MIPS. We 
refer readers to section II.C.6.f. of this final rule with comment 
period for the discussion regarding how we address performance category 
weighting for MIPS eligible clinicians for whom no measures or 
activities are applicable and available in a given performance 
category.
    In the CY 2017 Quality Payment Program final rule (81 FR 77048 
through 77049), we defined a non-patient facing MIPS eligible clinician 
for MIPS at Sec.  414.1305 as an individual MIPS eligible clinician 
that bills 100 or fewer patient-facing encounters (including Medicare 
telehealth services defined in section 1834(m) of the Act) during the 
non-patient facing determination period, and a group provided that more 
than 75 percent of the NPIs billing under the group's TIN meet the 
definition of a non-patient facing individual MIPS eligible clinician 
during the non-patient facing determination period. In order to account 
for the formation of virtual groups starting in the 2018 performance 
year and how non-patient facing determinations would apply to virtual 
groups, we need to modify the definition of a non-patient facing MIPS 
eligible clinician. Therefore, for performance periods occurring in 
2018 and future years, we proposed to modify the definition of a non-
patient facing MIPS eligible clinician at Sec.  414.1305 to mean an 
individual MIPS eligible clinician that bills 100 or fewer patient-
facing encounters (including Medicare telehealth services defined in 
section 1834(m) of the Act) during the non-patient facing determination 
period, and a group or virtual group provided that more than 75 percent 
of the NPIs billing under the group's TIN or within a virtual group, as 
applicable, meet the definition of a non-patient facing individual MIPS 
eligible clinician during the non-patient facing determination period 
(82 FR 30021).
    We considered a patient-facing encounter to be an instance in which 
the individual MIPS eligible clinician or group billed for items and 
services furnished such as general office visits, outpatient visits, 
and procedure codes under the PFS. We published the list of patient-
facing encounter codes for performance periods occurring in 2017 at 
qpp.cms.gov/resources/education. We intend to publish the list of 
patient-facing encounter codes for performance periods occurring in 
2018 at qpp.cms.gov by the end of 2017. The list of patient-facing 
encounter codes is used to determine the non-patient facing status of 
MIPS eligible clinicians.
    The list of patient-facing encounter codes includes two general 
categories of codes: Evaluation and Management (E&M) codes; and 
Surgical and Procedural codes. E&M codes capture clinician-patient 
encounters that occur in a variety of care settings, including office 
or other outpatient settings, hospital inpatient settings, emergency 
departments, and nursing facilities, in which clinicians utilize 
information provided by patients regarding history, present illness, 
and symptoms to determine the type of assessments to conduct. 
Assessments are conducted on the affected body area(s) or organ 
system(s) for clinicians to make medical decisions that establish a 
diagnosis or select a management option(s).
    Surgical and Procedural codes capture clinician-patient encounters 
that involve procedures, surgeries, and other medical services 
conducted by clinicians to treat medical conditions. In the case of 
many of these services, evaluation and management work is included in 
the payment for the single code instead of separately reported. 
Patient-facing encounter codes from both of these categories describe 
direct services furnished by eligible clinicians with impact on patient 
safety, quality of care, and health outcomes.
    For purposes of the non-patient facing policies under MIPS, the 
utilization of E&M codes and Surgical and Procedural codes allows for 
accurate identification of patient-facing encounters, and thus, 
accurate eligibility determinations regarding non-patient facing 
status. As a result, MIPS eligible clinicians considered non-patient 
facing are able to prepare to meet requirements applicable to non-
patient facing MIPS eligible clinicians. We proposed to continue 
applying these policies for purposes of the 2020 MIPS payment year and 
future years (82 FR 30021).
    As described in the CY 2017 Quality Payment Program final rule, we 
established the non-patient facing determination period for purposes of 
identifying non-patient facing MIPS eligible clinicians in advance of 
the performance period and during the performance period using 
historical and performance period claims data. This eligibility 
determination process allows us to begin identifying non-patient facing 
MIPS eligible clinicians prior to or shortly after the start of the 
performance period. The non-patient facing determination period is a 
24-month assessment period, which includes a two-segment analysis of 
claims data regarding patient-facing encounters during an initial 12-
month period prior to the performance period followed by another 12-
month period during the performance period. The initial 12-month 
segment of the non-patient facing determination period spans from the 
last 4 months of a calendar year 2 years prior to the performance 
period followed by the first 8 months of the next calendar year and 
includes a 60-day claims run out, which allows us to inform individual 
MIPS eligible clinicians and groups of their non-patient facing status 
during the month (December) prior to the start of the performance 
period. The second 12-month segment of the non-patient facing 
determination period spans from the last 4 months of a calendar year 1 
year prior to the performance period followed by the first 8 months of 
the performance period in the next calendar year and includes a 60-day 
claims run out, which will allow us to inform additional individual 
MIPS eligible clinicians and groups of their non-patient status during 
the performance period.
    However, based on our analysis of data from the initial segment of 
the non-patient facing determination period for performance periods 
occurring in 2017 (that is, data spanning from September 1, 2015 to 
August 31, 2016), we found that it may not be necessary to include a 
60-day claims run out since we could achieve a similar outcome for such 
eligibility determinations by utilizing a 30-day claims run out. In our 
comparison of data analysis results utilizing a 60-day claims run out 
versus a 30-day claims run out, there was a 1 percent decrease in data 
completeness (see Table 1 for data completeness regarding comparative 
analysis of a 60-day and 30-day claims run out). The small decrease in 
data completeness would not negatively impact individual MIPS eligible 
clinicians or groups regarding non-patient facing determinations. We 
believe that a 30-day claims run out would allow us to complete the 
analysis and provide such determinations in a more timely manner.

[[Page 53584]]



 Table 1--Percentages of Data Completeness for 60-Day and 30-Day Claims
                                 Run Out
------------------------------------------------------------------------
                                                 30-Day        60-Day
                Incurred year                  claims run    claims run
                                                  out *         out *
------------------------------------------------------------------------
2015........................................        97.1%         98.4%
------------------------------------------------------------------------
* Note: Completion rates are estimated and averaged at aggregated
  service categories and may not be applicable to subsets of these
  totals. For example, completion rates can vary by clinician due to
  claim processing practices, service mix, and post payment review
  activity. Completion rates vary from subsections of a calendar year;
  later portions of a given calendar year will be less complete than
  earlier ones. Completion rates vary due to variance in loading
  patterns due to technical, seasonal, policy, and legislative factors.
  Completion rates are a function of the incurred date used to process
  claims, and these factors will need to be updated if claims are
  processed on a claim from date or other methodology.

    For performance periods occurring in 2018 and future years, we 
proposed a modification to the non-patient facing determination period, 
in which the initial 12-month segment of the non-patient facing 
determination period would span from the last 4 months of a calendar 
year 2 years prior to the performance period followed by the first 8 
months of the next calendar year and include a 30-day claims run out; 
and the second 12-month segment of the non-patient facing determination 
period would span from the last 4 months of a calendar year 1 year 
prior to the performance period followed by the first 8 months of the 
performance period in the next calendar year and include a 30-day 
claims run out (82 FR 30022). The proposal would only change the 
duration of the claims run out, not the 12-month timeframes used for 
the first and second segments of data analysis.
    For purposes of the 2020 MIPS payment year, we would initially 
identify individual MIPS eligible clinicians and groups who are 
considered non-patient facing MIPS eligible clinicians based on 12 
months of data starting from September 1, 2016, to August 31, 2017. To 
account for the identification of additional individual MIPS eligible 
clinicians and groups that may qualify as non-patient facing during 
performance periods occurring in 2018, we would conduct another 
eligibility determination analysis based on 12 months of data starting 
from September 1, 2017, to August 31, 2018.
    Similarly, for future years, we would conduct an initial 
eligibility determination analysis based on 12 months of data 
(consisting of the last 4 months of the calendar year 2 years prior to 
the performance period and the first 8 months of the calendar year 
prior to the performance period) to determine the non-patient facing 
status of individual MIPS eligible clinicians and groups, and conduct 
another eligibility determination analysis based on 12 months of data 
(consisting of the last 4 months of the calendar year prior to the 
performance period and the first 8 months of the performance period) to 
determine the non-patient facing status of additional individual MIPS 
eligible clinicians and groups. We would not change the non-patient 
facing status of any individual MIPS eligible clinician or group 
identified as non-patient facing during the first eligibility 
determination analysis based on the second eligibility determination 
analysis. Thus, an individual MIPS eligible clinician or group that is 
identified as non-patient facing during the first eligibility 
determination analysis would continue to be considered non-patient 
facing for the duration of the performance period and MIPS payment year 
regardless of the results of the second eligibility determination 
analysis. We would conduct the second eligibility determination 
analysis to account for the identification of additional, previously 
unidentified individual MIPS eligible clinicians and groups that are 
considered non-patient facing.
    Additionally, in the CY 2017 Quality Payment Program final rule (81 
FR 77241), we established a policy regarding the re-weighting of the 
advancing care information performance category for non-patient facing 
MIPS eligible clinicians. Specifically, MIPS eligible clinicians who 
are considered to be non-patient facing will have their advancing care 
information performance category automatically reweighted to zero (81 
FR 77241). For groups that are considered to be non-patient facing 
(that is, more than 75 percent of the NPIs billing under the group's 
TIN meet the definition of a non-patient facing individual MIPS 
eligible clinician) during the non-patient facing determination period, 
we are finalizing in section II.C.7.b.(3) of this final rule with 
comment period to automatically reweight their advancing care 
information performance category to zero. We proposed to continue 
applying these policies for purposes of the 2020 MIPS payment year and 
future years.
    The following is a summary of the public comments received on the 
``Non-Patient Facing MIPS Eligible Clinicians'' proposals and our 
responses:
    Comment: Several commenters supported the policy to define non-
patient facing clinicians as individual eligible clinicians billing 100 
or fewer encounters, and group or virtual groups to be defined as non-
patient facing if more than 75 percent of eligible clinicians billing 
under the group meets the individual clinician definition. One 
commenter appreciated the flexibility we are demonstrating in 
considering the use of telehealth. Another commenter recommended we 
implement the same thresholds for rural and HPSA practices.
    Response: We are finalizing for performance periods occurring in 
2018 and future years that at Sec.  414.1305 non-patient facing MIPS 
eligible clinician means an individual MIPS eligible clinician that 
bills 100 or fewer patient-facing encounters (including Medicare 
telehealth services defined in section 1834(m) of the Act) during the 
non-patient facing determination period, and a group or virtual group 
provided that more than 75 percent of the NPIs billing under the 
group's TIN or within a virtual group, as applicable, meet the 
definition of a non-patient facing individual MIPS eligible clinician 
during the non-patient facing determination period.
    Comment: Several commenters did not support the proposed definition 
of non-patient facing as an individual MIPS eligible clinician that 
bills 100 or fewer patient-facing encounters during the non-patient 
facing determination period, and a group provided that more than 75 
percent of the NPIs billing under the group's TIN meet the definition 
of a non-patient facing individual MIPS eligible clinician during the 
non-patient facing determination period. One commenter recommended that 
the definition of a non-patient facing clinician be defined at the 
individual clinician level and not be applied at a group level. Another 
commenter did not support applying the non-patient facing definition to 
pathologists using PECOS, but rather believed all pathologists should 
be automatically identified as non-patient facing.
    Response: We do not agree with the commenters who did not support 
the proposed definition of a non-patient facing MIPS eligible clinician 
at the individual or group level. We weighed several options when 
considering the appropriate definition of non-patient facing MIPS 
eligible clinicians and believe we have established an appropriate 
threshold that provides the most appropriate representation of a non-
patient facing MIPS eligible clinician. The definition of a non-patient 
facing MIPS eligible clinician is based on a methodology that would 
allow us to more accurately identify MIPS eligible clinicians who are 
non-patient facing by applying a threshold to recognize that a MIPS 
eligible clinician who furnishes almost exclusively non-

[[Page 53585]]

patient facing services should be treated as a non-patient facing MIPS 
eligible clinician despite furnishing a small number of patient-facing 
services. This approach also allows us to determine if an individual 
clinician or a group of clinicians is non-patient facing. We believe 
that having the determination of non-patient facing available at the 
individual and group level provides further flexibilities for MIPS 
eligible clinicians on the options available to them for participation 
within the program. Our methodology used to identify non-patient facing 
MIPS eligible clinicians included a quantitative, comparative analysis 
of claims and HCPCS code data. We refer commenters to CY 2017 Quality 
Payment Program Final Rule (81 FR 77041 through 77049) for a full 
discussion on the logic for which clinicians are eligible to be non-
patient facing MIPS eligible clinicians. We agree and intend to provide 
the non-patient facing determination prior to the performance period 
following the non-patient facing determination period as discussed in 
section II.C.1.e. of this final rule with comment period. Regarding the 
comment disagreeing with applying the non-patient facing definition to 
pathologists using PECOS, we note that we are not utilizing PECOS for 
the non-patient facing determination, rather we utilize Part B claims 
data.
    Comment: Two commenters recommended that we release all patient-
facing codes through formal notice-and-comment rulemaking rather than 
subregulatory guidance.
    Response: In the CY 2018 Quality Payment Program proposed rule (82 
FR 30021), we noted that we consider a patient-facing encounter to be 
an instance in which the individual MIPS eligible clinician or group 
billed for items and services furnished such as general office visits, 
outpatient visits, and procedure codes under the PFS, and we described 
in detail two general categories of codes included in this list of 
codes, specifically, E&M codes and Surgical and Procedural codes, and 
our rationale for including these codes, which we proposed to continue 
applying for purposes of the 2020 MIPS payment year and future years. 
Therefore, we do not believe it is necessary to specify each individual 
code in notice-and-comment rulemaking. Moreover, we are unable to 
provide the patient-facing codes through the notice-and-comment 
rulemaking as the final list of Current Procedural Terminology (CPT) 
codes used to determine patient facing encounters are often not 
available in conjunction with the proposed and final rulemaking 
timelines. However, we intend to publish the patient-facing codes as 
close to when the final rule with comment period is issued as possible 
and prior to the start of the performance period. We will adopt any 
changes to this policy through future rulemaking as necessary.
    Comment: Several commenters supported the proposed policy on 
determination periods. The commenters agreed with the proposed policy 
to use 2 determination periods. A few commenters recommended that we 
notify MIPS eligible clinicians and groups prior to the start of the 
performance period by either including such information in the MIPS 
eligibility notifications sent to eligible clinicians or responding to 
MIPS eligible clinician or group requests for information. Two 
commenters recommended that we allow an appeal process or attestation 
by MIPS eligible clinicians for the non-patient facing designation.
    Response: We agree with the commenters regarding the non-patient 
facing determination period and that MIPS eligible clinicians should be 
notified prior to the performance period regarding their eligibility 
status. In the CY 2017 Quality Payment Program final rule (81 FR 77043 
through 77048), we established the non-patient facing determination 
period for purposes of identifying non-patient facing MIPS eligible 
clinicians in advance of the performance period and during the 
performance period using historical and performance period claims data. 
In addition, we would like to note that MIPS eligible clinicians may 
access the Quality Payment Program Web site at www.qpp.cms.gov and 
check if they are required to submit data to MIPS by entering their NPI 
into the online tool. In response to the comment regarding appeals for 
non-patient facing status, if a MIPS eligible clinician disagrees with 
the non-patient facing determination, we note that clinicians can 
contact the Quality Payment Program Service Center which may be reached 
at 1-866-288-8292 (TTY 1-877-715-6222), available Monday through 
Friday, 8:00 a.m.-8:00 p.m. Eastern Time or via email at 
[email protected]. If an error in the non-patient facing determination is 
discovered, we will update the MIPS eligible clinicians' status 
accordingly.
    Final Action: After consideration of the public comments, we are 
finalizing for performance periods occurring in 2018 and future years 
that at Sec.  414.1305 non-patient facing MIPS eligible clinician means 
an individual MIPS eligible clinician that bills 100 or fewer patient-
facing encounters (including Medicare telehealth services defined in 
section 1834(m) of the Act) during the non-patient facing determination 
period, and a group or virtual group provided that more than 75 percent 
of the NPIs billing under the group's TIN or within a virtual group, as 
applicable, meet the definition of a non-patient facing individual MIPS 
eligible clinician during the non-patient facing determination period. 
In addition, we are finalizing that for performance periods occurring 
in 2018 and future years that for purposes of non-patient facing MIPS 
eligible clinicians, we will utilize E&M codes and Surgical and 
Procedural codes for accurate identification of patient-facing 
encounters, and thus, accurate eligibility determinations regarding 
non-patient facing status. Further, we are finalizing that a patient-
facing encounter is considered to be an instance in which the 
individual MIPS eligible clinician or group billed for items and 
services furnished such as general office visits, outpatient visits, 
and procedure codes under the PFS. Finally, we are finalizing that for 
performance periods occurring in 2018 and future years, that for the 
non-patient facing determination period, in which the initial 12-month 
segment of the non-patient facing determination period would span from 
the last 4 months of a calendar year 2 years prior to the performance 
period followed by the first 8 months of the next calendar year and 
include a 30-day claims run out; and the second 12-month segment of the 
non-patient facing determination period would span from the last 4 
months of a calendar year 1 year prior to the performance period 
followed by the first 8 months of the performance period in the next 
calendar year and include a 30-day claims run out.
f. MIPS Eligible Clinicians Who Practice in Critical Access Hospitals 
Billing Under Method II (Method II CAHs)
    In the CY 2017 Quality Payment Program final rule (81 FR 77049), we 
noted that MIPS eligible clinicians who practice in CAHs that bill 
under Method I (Method I CAHs), the MIPS payment adjustment would apply 
to payments made for items and services billed by MIPS eligible 
clinicians, but it would not apply to the facility payment to the CAH 
itself. For MIPS eligible clinicians who practice in Method II CAHs and 
have not assigned their billing rights to the CAH, the MIPS payment 
adjustment would apply in the same manner as for MIPS eligible 
clinicians who bill for items and services in Method I CAHs. As 
established in the CY 2017 Quality Payment Program final rule (81 FR 
77051), the MIPS payment adjustment will apply to Method II CAH 
payments

[[Page 53586]]

under section 1834(g)(2)(B) of the Act when MIPS eligible clinicians 
who practice in Method II CAHs have assigned their billing rights to 
the CAH.
    We refer readers to the CY 2017 Quality Payment Program final rule 
(81 FR 77049 through 77051) for our discussion of MIPS eligible 
clinicians who practice in Method II CAHs.
g. MIPS Eligible Clinicians Who Practice in Rural Health Clinics (RHCs) 
or Federally Qualified Health Centers (FQHCs)
    As established in the CY 2017 Quality Payment Program final rule 
(81 FR 77051 through 77053), services furnished by an eligible 
clinician under the RHC or FQHC methodology, will not be subject to the 
MIPS payments adjustments. As noted, these eligible clinicians have the 
option to voluntarily report on applicable measures and activities for 
MIPS, in which the data received will not be used to assess their 
performance for the purpose of the MIPS payment adjustment.
    We refer readers to the CY 2017 Quality Payment Program final rule 
(81 FR 77051 through 77053) for our discussion of MIPS eligible 
clinicians who practice in RHCs or FQHCs.
h. MIPS Eligible Clinicians Who Practice in Ambulatory Surgical Centers 
(ASCs), Home Health Agencies (HHAs), Hospice, and Hospital Outpatient 
Departments (HOPDs)
    Section 1848(q)(6)(E) of the Act provides that the MIPS payment 
adjustment is applied to the amount otherwise paid under Part B with 
respect to the items and services furnished by a MIPS eligible 
clinician during a year. Some eligible clinicians may not receive MIPS 
payment adjustments due to their billing methodologies. If a MIPS 
eligible clinician furnishes items and services in an ASC, HHA, 
Hospice, and/or HOPD and the facility bills for those items and 
services (including prescription drugs) under the facility's all-
inclusive payment methodology or prospective payment system 
methodology, the MIPS adjustment would not apply to the facility 
payment itself. However, if a MIPS eligible clinician furnishes other 
items and services in an ASC, HHA, Hospice, and/or HOPD and bills for 
those items and services separately, such as under the PFS, the MIPS 
adjustment would apply to payments made for such items and services. 
Such items and services would also be considered for purposes of 
applying the low-volume threshold. Therefore, we proposed that services 
furnished by an eligible clinician that are payable under the ASC, HHA, 
Hospice, or HOPD methodology would not be subject to the MIPS payments 
adjustments (82 FR 30023). However, these eligible clinicians have the 
option to voluntarily report on applicable measures and activities for 
MIPS, in which case the data received would not be used to assess their 
performance for the purpose of the MIPS payment adjustment. We note 
that eligible clinicians who bill under both the PFS and one of these 
other billing methodologies (ASC, HHA, Hospice, and/or HOPD) may be 
required to participate in MIPS if they exceed the low-volume threshold 
and are otherwise eligible clinicians; in such case, the data reported 
would be used to determine their MIPS payment adjustment.
    The following is a summary of the public comments received on the 
``MIPS Eligible Clinicians Who Practice in ASCs, HHAs, HOPDs'' proposal 
and our responses:
    Comment: A few commenters agreed with the proposal that services 
furnished by an eligible clinician that are payable under the ASC, HHA, 
Hospice, or Outpatient payment methodology would not be subject to the 
MIPS payment adjustments.
    Response: We appreciate the commenters' support. We are finalizing 
that services furnished by an eligible clinician that are payable under 
the ASC, HHA, Hospice, or HOPD methodology will not be subject to the 
MIPS payments adjustments and that such data will not be utilized for 
MIPS eligibility purposes.
    Final Action: After consideration of the public comments, we are 
finalizing that services furnished by an eligible clinician that are 
payable under the ASC, HHA, Hospice, or HOPD methodology will not be 
subject to the MIPS payments adjustments and that such data will not be 
utilized for MIPS eligibility purposes, as proposed.
i. MIPS Eligible Clinician Identifiers
    As described in the CY 2017 Quality Payment Program final rule (81 
FR 77057), we established the use of multiple identifiers that allow 
MIPS eligible clinicians to be measured as an individual or 
collectively through a group's performance and that the same identifier 
be used for all four performance categories. While we have multiple 
identifiers for participation and performance, we established the use 
of a single identifier, TIN/NPI, for applying the MIPS payment 
adjustment, regardless of how the MIPS eligible clinician is assessed.
(1) Individual Identifiers
    As established in the CY 2017 Quality Payment Program final rule 
(81 FR 77058), we define a MIPS eligible clinician at Sec.  414.1305 to 
mean the use of a combination of unique billing TIN and NPI combination 
as the identifier to assess performance of an individual MIPS eligible 
clinician. Each unique TIN/NPI combination is considered a different 
MIPS eligible clinician, and MIPS performance is assessed separately 
for each TIN under which an individual bills.
(2) Group Identifiers for Performance
    As established in the CY 2017 Quality Payment Program final rule 
(81 FR 77059), we codified the definition of a group at Sec.  414.1305 
to mean a group that consists of a single TIN with two or more eligible 
clinicians (including at least one MIPS eligible clinician), as 
identified by their individual NPI, who have reassigned their billing 
rights to the TIN.
(3) APM Entity Group Identifiers for Performance
    As described in the CY 2017 Quality Payment Program final rule (81 
FR 77060), we established that each eligible clinician who is a 
participant of an APM Entity is identified by a unique APM participant 
identifier. The unique APM participant identifier is a combination of 
four identifiers: (1) APM Identifier (established by CMS; for example, 
XXXXXX); (2) APM Entity identifier (established under the APM by CMS; 
for example, AA00001111); (3) TIN(s) (9 numeric characters; for 
example, XXXXXXXXX); (4) EP NPI (10 numeric characters; for example, 
1111111111). We codified the definition of an APM Entity group at Sec.  
414.1305 to mean a group of eligible clinicians participating in an APM 
Entity, as identified by a combination of the APM identifier, APM 
Entity identifier, TIN, and NPI for each participating eligible 
clinician.
2. Exclusions
a. New Medicare-Enrolled Eligible Clinician
    As established in the CY 2017 Quality Payment Program final rule 
(81 FR 77061 through 77062), we defined a new Medicare-enrolled 
eligible clinician at Sec.  414.1305 as a professional who first 
becomes a Medicare-enrolled eligible clinician within the PECOS during 
the performance period for a year and had not previously submitted 
claims under Medicare such as an individual, an entity, or a part of a 
clinician group or under a different billing number or tax identifier. 
Additionally, we established

[[Page 53587]]

at Sec.  414.1310(c) that these eligible clinicians will not be treated 
as a MIPS eligible clinician until the subsequent year and the 
performance period for such subsequent year. We established at Sec.  
414.1310(d) that in no case would a MIPS payment adjustment apply to 
the items and services furnished during a year by new Medicare-enrolled 
eligible clinicians for the applicable performance period.
    We used the term ``new Medicare-enrolled eligible clinician 
determination period'' to refer to the 12 months of a calendar year 
applicable to the performance period. During the new Medicare-enrolled 
eligible clinician determination period, we conduct eligibility 
determinations on a quarterly basis to the extent that is technically 
feasible to identify new Medicare-enrolled eligible clinicians that 
would be excluded from the requirement to participate in MIPS for the 
applicable performance period.
b. Qualifying APM Participant (QP) and Partial Qualifying APM 
Participant (Partial QP)
    In the CY 2017 Quality Payment Program final rule (81 FR 77062), we 
established at Sec.  414.1305 that a QP (as defined at Sec.  414.1305) 
is not a MIPS eligible clinician, and therefore, is excluded from MIPS. 
Also, we established that a Partial QP (as defined at Sec.  414.1305) 
who does not report on applicable measures and activities that are 
required to be reported under MIPS for any given performance period in 
a year is not a MIPS eligible clinician, and therefore, is excluded 
from MIPS.
c. Low-Volume Threshold
    Section 1848(q)(1)(C)(ii)(III) of the Act provides that the 
definition of a MIPS eligible clinician does not include eligible 
clinicians who are below the low-volume threshold selected by the 
Secretary under section 1848(q)(1)(C)(iv) of the Act for a given year. 
Section 1848(q)(1)(C)(iv) of the Act requires the Secretary to select a 
low-volume threshold to apply for the purposes of this exclusion which 
may include one or more of the following: (1) The minimum number, as 
determined by the Secretary, of Part B-enrolled individuals who are 
treated by the eligible clinician for a particular performance period; 
(2) the minimum number, as determined by the Secretary, of items and 
services furnished to Part B-enrolled individuals by the eligible 
clinician for a particular performance period; and (3) the minimum 
amount, as determined by the Secretary, of allowed charges billed by 
the eligible clinician for a particular performance period.
    In the CY 2017 Quality Payment Program final rule (81 FR 77069 
through 77070), we defined MIPS eligible clinicians or groups who do 
not exceed the low-volume threshold at Sec.  414.1305 as an individual 
MIPS eligible clinician or group who, during the low-volume threshold 
determination period, has Medicare Part B allowed charges less than or 
equal to $30,000 or provides care for 100 or fewer Part B-enrolled 
Medicare beneficiaries. We established at Sec.  414.1310(b) that for a 
year, eligible clinicians who do not exceed the low-volume threshold 
(as defined at Sec.  414.1305) are excluded from MIPS for the 
performance period for a given calendar year.
    In the CY 2017 Quality Payment Program final rule (81 FR 77069 
through 77070), we defined the low-volume threshold determination 
period to mean a 24-month assessment period, which includes a two-
segment analysis of claims data during an initial 12-month period prior 
to the performance period followed by another 12-month period during 
the performance period. The initial 12-month segment of the low-volume 
threshold determination period spans from the last 4 months of a 
calendar year 2 years prior to the performance period followed by the 
first 8 months of the next calendar year and includes a 60-day claims 
run out, which allows us to inform eligible clinicians and groups of 
their low-volume status during the month (December) prior to the start 
of the performance period. The second 12-month segment of the low-
volume threshold determination period spans from the last 4 months of a 
calendar year 1 year prior to the performance period followed by the 
first 8 months of the performance period in the next calendar year and 
includes a 60-day claims run out, which allows us to inform additional 
eligible clinicians and groups of their low-volume status during the 
performance period.
    We recognize that individual MIPS eligible clinicians and groups 
that are small practices or practicing in designated rural areas face 
unique dynamics and challenges such as fiscal limitations and workforce 
shortages, but serve as a critical access point for care and provide a 
safety net for vulnerable populations. Claims data shows that 
approximately 15 percent of individual MIPS eligible clinicians (TIN/
NPIs) are considered to be practicing in rural areas after applying all 
exclusions. Also, we have heard from stakeholders that MIPS eligible 
clinicians practicing in small practices and designated rural areas 
tend to have a patient population with a higher proportion of older 
adults, as well as higher rates of poor health outcomes, co-
morbidities, chronic conditions, and other social risk factors, which 
can result in the costs of providing care and services being 
significantly higher compared to non-rural areas. We also have heard 
from many solo practitioners and small practices that still face 
challenges and additional resource burden in participating in the MIPS.
    In the CY 2017 Quality Payment Program final rule, we did not 
establish an adjustment for social risk factors in assessing and 
scoring performance. In response to the CY 2017 Quality Payment Program 
final rule, we received public comments indicating that individual MIPS 
eligible clinicians and groups practicing in designated rural areas 
would be negatively impacted and at a disadvantage if assessment and 
scoring methodology did not adjust for social risk factors. 
Additionally, commenters expressed concern that such individual MIPS 
eligible clinicians and groups may be disproportionately more 
susceptible to lower performance scores across all performance 
categories and negative MIPS payments adjustments, and as a result, 
such outcomes may further strain already limited fiscal resources and 
workforce shortages, and negatively impact access to care (reduction 
and/or elimination of available services).
    After the consideration of stakeholder feedback, we proposed to 
modify the low-volume threshold policy established in the CY 2017 
Quality Payment Program final rule (82 FR 30024). We stated that we 
believe that increasing the dollar amount and beneficiary count of the 
low-volume threshold would further reduce the number of eligible 
clinicians that are required to participate in the MIPS, which would 
reduce the burden on individual MIPS eligible clinicians and groups 
practicing in small practices and designated rural areas. Based on our 
analysis of claims data, we found that increasing the low-volume 
threshold to exclude individual eligible clinicians or groups that have 
Medicare Part B allowed charges less than or equal to $90,000 or that 
provide care for 200 or fewer Part B-enrolled Medicare beneficiaries 
will exclude approximately 134,000 additional clinicians from MIPS from 
the approximately 700,000 clinicians that would have been eligible 
based on the low-volume threshold that was finalized in the CY 2017 
Quality Payment Program final rule. Almost half of the additionally 
excluded clinicians are in small practices, and approximately 17 
percent are clinicians from practices in designated rural areas. 
Applying this

[[Page 53588]]

criterion decreases the percentage of the MIPS eligible clinicians that 
come from small practices. For example, prior to any exclusions, 
clinicians in small practices represent 35 percent of all clinicians 
billing Part B services. After applying the eligibility criteria for 
the CY 2017 Quality Payment Program final rule, MIPS eligible 
clinicians in small practices represent approximately 27 percent of the 
clinicians eligible for MIPS; however, with the increased low-volume 
threshold, approximately 22 percent of the clinicians eligible for MIPS 
are from small practices. In our analysis, the proposed changes to the 
low-volume threshold showed little impact on MIPS eligible clinicians 
from practices in designated rural areas. MIPS eligible clinicians from 
practices in designated rural areas account for15 to 16 percent of the 
total MIPS eligible clinician population. We note that, due to data 
limitations, we assessed rural status based on the status of individual 
TIN/NPI and did not model any group definition for practices in 
designated rural areas.
    We believe that increasing the number of such individual eligible 
clinicians and groups excluded from MIPS participation would reduce 
burden and mitigate, to the extent feasible, the issue surrounding 
confounding variables impacting performance under the MIPS. Therefore, 
beginning with the 2018 MIPS performance period, we proposed to 
increase the low-volume threshold. Specifically, at Sec.  414.1305, we 
proposed to define an individual MIPS eligible clinician or group who 
does not exceed the low-volume threshold as an individual MIPS eligible 
clinician or group who, during the low-volume threshold determination 
period, has Medicare Part B allowed charges less than or equal to 
$90,000 or provides care for 200 or fewer Part B-enrolled Medicare 
beneficiaries. This would mean that approximately 37 percent of 
individual eligible clinicians and groups would be eligible for MIPS 
based on the low-volume threshold exclusion (and the other exclusions). 
However, approximately 65 percent of Medicare payments would still be 
captured under MIPS as compared to 72.2 percent of Medicare payments 
under the CY 2017 Quality Payment Program final rule.
    We recognize that increasing the dollar amount and beneficiary 
count of the low-volume threshold would increase the number of 
individual eligible clinicians and groups excluded from MIPS. We 
assessed various levels of increases and found that $90,000 as the 
dollar amount and 200 as the beneficiary count balances the need to 
account for individual eligible clinicians and groups who face 
additional participation burden while not excluding a significant 
portion of the clinician population.
    Eligible clinicians who do not exceed the low-volume threshold (as 
defined at Sec.  414.1305) are excluded from MIPS for the performance 
period with respect to a year. The low-volume threshold also applies to 
eligible clinicians who practice in APMs under the APM scoring standard 
at the APM Entity level, in which APM Entities do not exceed the low-
volume threshold. In such cases, the eligible clinicians participating 
in the MIPS APM Entity would be excluded from the MIPS requirements for 
the applicable performance period and not subject to a MIPS payment 
adjustment for the applicable year. Such an exclusion would not affect 
an APM Entity's QP determination if the APM Entity is an Advanced APM.
    In the CY 2017 Quality Payment Program final rule, we established 
the low-volume threshold determination period to refer to the timeframe 
used to assess claims data for making eligibility determinations for 
the low-volume threshold exclusion (81 FR 77069 through 77070). We 
defined the low-volume threshold determination period to mean a 24-
month assessment period, which includes a two-segment analysis of 
claims data during an initial 12-month period prior to the performance 
period followed by another 12-month period during the performance 
period. Based on our analysis of data from the initial segment of the 
low-volume threshold determination period for performance periods 
occurring in 2017 (that is, data spanning from September 1, 2015 to 
August 31, 2016), we found that it may not be necessary to include a 
60-day claims run out since we could achieve a similar outcome for such 
eligibility determinations by utilizing a 30-day claims run out.
    In our comparison of data analysis results utilizing a 60-day 
claims run out versus a 30-day claims run out, there was a 1 percent 
decrease in data completeness. The small decrease in data completeness 
would not substantially impact individual MIPS eligible clinicians or 
groups regarding low-volume threshold determinations. We believe that a 
30-day claims run out would allow us to complete the analysis and 
provide such determinations in a more timely manner. For performance 
periods occurring in 2018 and future years, we proposed a modification 
to the low-volume threshold determination period, in which the initial 
12-month segment of the low-volume threshold determination period would 
span from the last 4 months of a calendar year 2 years prior to the 
performance period followed by the first 8 months of the next calendar 
year and include a 30-day claims run out; and the second 12-month 
segment of the low-volume threshold determination period would span 
from the last 4 months of a calendar year 1 year prior to the 
performance period followed by the first 8 months of the performance 
period in the next calendar year and include a 30-day claims run out 
(82 FR 30025). We stated that the proposal would only change the 
duration of the claims run out, not the 12-month timeframes used for 
the first and second segments of data analysis.
    For purposes of the 2020 MIPS payment year, we would initially 
identify individual eligible clinicians and groups that do not exceed 
the low-volume threshold based on 12 months of data starting from 
September 1, 2016 to August 31, 2017. To account for the identification 
of additional individual eligible clinicians and groups that do not 
exceed the low-volume threshold during performance periods occurring in 
2018, we would conduct another eligibility determination analysis based 
on 12 months of data starting from September 1, 2017 to August 31, 
2018. We would not change the low-volume status of any individual 
eligible clinician or group identified as not exceeding the low-volume 
threshold during the first eligibility determination analysis based on 
the second eligibility determination analysis. Thus, an individual 
eligible clinician or group that is identified as not exceeding the 
low-volume threshold during the first eligibility determination 
analysis would continue to be excluded from MIPS for the duration of 
the performance period regardless of the results of the second 
eligibility determination analysis. We established our policy to 
include two eligibility determination analyses in order to prevent any 
potential confusion for an individual eligible clinician or group to 
know whether or not participate in MIPS; also, such policy makes it 
clear from the onset as to which individual eligible clinicians and 
groups would be required to participate in MIPS. We would conduct the 
second eligibility determination analysis to account for the 
identification of additional, previously unidentified individual 
eligible clinicians and groups who do not exceed the low-volume 
threshold. We note that low-volume threshold determinations are made at 
the individual and group level, and not at the virtual group level.
    As noted above, section 1848(q)(1)(C)(iv) of the Act requires the

[[Page 53589]]

Secretary to select a low-volume threshold to apply for the purposes of 
this exclusion which may include one or more of the following: (1) The 
minimum number, as determined by the Secretary, of Part B-enrolled 
individuals who are treated by the eligible clinician for a particular 
performance period; (2) the minimum number, as determined by the 
Secretary, of items and services furnished to Part B-enrolled 
individuals by the eligible clinician for a particular performance 
period; and (3) the minimum amount, as determined by the Secretary, of 
allowed charges billed by the eligible clinician for a particular 
performance period. We have established a low-volume threshold that 
accounts for the minimum number of Part-B enrolled individuals who are 
treated by an eligible clinician and that accounts for the minimum 
amount of allowed charges billed by an eligible clinician. We did not 
make proposals specific to a minimum number of items and service 
furnished to Part-B enrolled individuals by an eligible clinician.
    In order to expand the ways in which claims data could be analyzed 
for purposes of determining a more comprehensive assessment of the low-
volume threshold, we have assessed the option of establishing a low-
volume threshold for items and services furnished to Part-B enrolled 
individuals by an eligible clinician. We have considered defining items 
and services by using the number of patient encounters or procedures 
associated with a clinician. Defining items and services by patient 
encounters would assess each patient per visit or encounter with the 
eligible clinician. We believe that defining items and services by 
using the number of patient encounters or procedures is a simple and 
straightforward approach for stakeholders to understand. However, we 
are concerned that using this unit of analysis could incentivize 
clinicians to focus on volume of services rather than the value of 
services provided to patients. Defining items and services by procedure 
would tie a specific clinical procedure furnished to a patient to a 
clinician. We solicited public comment on the methods of defining items 
and services furnished by clinicians described in this paragraph above 
and alternate methods of defining items and services (82 FR 30025 
through 30026).
    For the individual eligible clinicians and groups that would be 
excluded from MIPS participation as a result of an increased low-volume 
threshold, we believe that in future years it would be beneficial to 
provide, to the extent feasible, such individual eligible clinicians 
and groups with the option to opt-in to MIPS participation if they 
might otherwise be excluded under the low-volume threshold, such as 
where they only meet one of the threshold determinations (including a 
third determination based on Part B items and services, if 
established). For example, if a clinician meets the low-volume 
threshold of $90,000 in allowed charges, but does not meet the 
threshold of 200 patients or, if established, the threshold pertaining 
to Part B items and services, we believe the clinician should, to the 
extent feasible, have the opportunity to choose whether or not to 
participate in the MIPS and be subject to MIPS payment adjustments. We 
recognize that this choice would present additional complexity to 
clinicians in understanding all of their available options and may 
impose additional burden on clinicians by requiring them to notify us 
of their decision. Because of these concerns and our desire to 
establish options in a way that is a low-burden and user-focused 
experience for all MIPS eligible clinicians, we would not be able to 
offer this additional flexibility until performance periods occurring 
in 2019. Therefore, as a means of expanding options for clinicians and 
offering them the ability to participate in MIPS if they otherwise 
would not be included, for the purposes of the 2021 MIPS payment year, 
we proposed to provide clinicians the ability to opt-in to the MIPS if 
they meet or exceed one, but not all, of the low-volume threshold 
determinations, including as defined by dollar amount, beneficiary 
count or, if established, items and services (82 FR 30026).
    We note that there may be additional considerations we should 
address for scenarios in which an individual eligible clinician or a 
group does not exceed the low-volume threshold and opts-in to 
participate in MIPS. We therefore sought comment on any additional 
considerations we should address when establishing this opt-in policy. 
Additionally, we note that there is the potential with this opt-in 
policy for there to be an impact on our ability to create quality 
benchmarks that meet our sample size requirements. For example, if 
particularly small practices or solo practitioners with low Part B 
beneficiary volumes opt-in, such clinicians may lack sufficient sample 
size to be scored on many quality measures, especially measures that do 
not apply to all of a MIPS eligible clinician's patients. We therefore 
sought comment on how to address any potential impact on our ability to 
create quality benchmarks that meet our sample size requirements (82 FR 
30026).
    The following is a summary of the public comments received on the 
``Low-Volume Threshold'' proposals and our responses:
    Comment: Many commenters supported raising the low-volume threshold 
to exclude an individual MIPS eligible clinician or group who, during 
the low-volume threshold determination period, has Medicare Part B 
allowed charges less than or equal to $90,000 or provides care for 200 
or fewer Part B-enrolled Medicare beneficiaries. Several commenters 
further suggested that we retroactively apply the threshold to the 2017 
MIPS performance period because changing the low-volume threshold for 
the 2018 MIPS performance period would create confusion, complicate 
operational and strategic planning for eligible clinicians, and create 
inefficiencies for clinicians. One commenter noted that we has not yet 
issued the required second round of reports notifying MIPS eligible 
clinicians whether they are below the low-volume threshold, so it would 
be technically feasible to implement the lower threshold before the end 
of the CY 2017 reporting period. A few commenters supported the 
proposal but recommended that we maintain the current, lower low-volume 
threshold for at least 2, 3, or more years to allow for planning and 
investment by clinicians in the program.
    Response: We appreciate the support from commenters who supported 
raising the low-volume threshold. We are finalizing our proposal to 
define at Sec.  414.1305 an individual eligible clinician or group that 
does not exceed the low-volume threshold as an individual eligible 
clinician or group that, during the low-volume threshold determination 
period, has Medicare Part B allowed charges less than or equal to 
$90,000 or provides care for 200 or fewer Part B-enrolled Medicare 
beneficiaries. We do not believe that we have the flexibility to 
retroactively apply the revised low-volume threshold to the 2017 MIPS 
performance period threshold. We are aware that by finalizing this 
policy, some MIPS eligible clinicians who were eligible to participate 
in MIPS for Year 1 will be excluded for Year 2. However, we would like 
to note that those MIPS eligible clinicians may still participate in 
Year 1. Finally, we agree with the commenter that there are benefits of 
maintaining the same low-volume threshold for several years and will 
take this into consideration in future years.
    Comment: Several commenters did not support the proposed low-volume 
threshold because the commenters believed the low-volume threshold

[[Page 53590]]

should be raised further to exclude more clinicians. Several of those 
commenters specifically recommended that we set the threshold no lower 
than $100,000 in Medicare Part B charges and to only apply to practices 
with 10 or fewer eligible clinicians.
    Response: We disagree with the commenters regarding raising the 
low-volume threshold further. Based on our data analysis, applying the 
proposed criterion decreases the percentage of MIPS eligible clinicians 
that come from small practices. We note that from our updated data 
models we found that the revised low-volume threshold will exclude 
approximately 123,000 additional clinicians from MIPS from the 
approximately 744,000 clinicians that would have been eligible based on 
the low-volume threshold that was finalized in the CY 2017 Quality 
Payment Program final rule. We believe that if we were to raise the 
low-volume threshold further, we may prevent medium size practices that 
wish to participate from the opportunity to receive an upward 
adjustment and would have fewer clinicians engaged in value-based care. 
We believe the finalized low-volume threshold strikes the appropriate 
balance with the need to account for individual MIPS eligible 
clinicians and groups who face additional participation burden while 
not excluding a significant portion of the clinician population. We are 
finalizing the low-volume threshold to exclude an individual eligible 
clinician or group that, during the low-volume threshold determination 
period, has Medicare Part B allowed charges less than or equal to 
$90,000 or provides care for 200 or fewer Part B-enrolled Medicare 
beneficiaries.
    Comment: Many commenters did not support raising the low-volume 
threshold for the 2018 MIPS performance period because they believed it 
would be unfair to clinicians who were already participating or planned 
to participate in MIPS in future years. The commenters noted that 
clinicians may have already invested in MIPS participation. Many 
commenters did not support the proposed low-volume threshold because 
they believed that raising the low-volume threshold would reduce 
payment and incentives for excluded clinicians to participate in value-
based care, which would create additional quality and reimbursement 
disparities for the beneficiaries seen by the excluded clinicians, 
creating a 2-tiered system of clinicians and related beneficiaries that 
are participating in value-based care. The commenters noted that 
raising the low-volume threshold would signal to the industry that we 
are not focused on transitioning to value-based payment and care. A few 
commenters expressed concern that raising the low-volume threshold 
would create further disparities in quality between urban and rural 
clinicians based on the reduced incentives for rural clinicians to 
participate in value-based purchasing programs. One of these commenters 
strongly recommended that we study the impact on the rural health 
industry prior to implementing the increased low-volume threshold. Many 
commenters noted that excluding more clinicians would risk dismantling 
the EHR infrastructure that has developed over recent years as 
additional practices opt-out of participation in programs designed to 
increase adoption and use of EHRs, wasting the billions of dollars we 
have invested to date in EHRs. The commenters believed that reduction 
in use of EHRs will affect participating clinicians as well by 
hampering connectivity and information sharing between excluded 
clinicians and participating clinicians. Some commenters also stated 
that decreased investment in EHRs by excluded clinicians will drive 
greater disparities in care quality between clinicians who are engaged 
in value-based purchasing and those who are not. One commenter strongly 
recommended that we delay implementation of the proposed low-volume 
threshold. Another commenter recommended that, rather than exclude 
clinicians from MIPS, we should allow clinicians to continue the pick-
your-pace approach and continue participating in MIPS.
    Response: We acknowledge there will be MIPS eligible clinicians who 
were eligible for Year 1 of MIPS that are no longer eligible for Year 2 
of MIPS. However, from our analyses, the MIPS eligible clinicians 
affected are mainly smaller practices and practices in rural areas, 
many of which have raised concerns regarding their ability to 
participate in MIPS. We want to encourage all clinicians to participate 
in value-based care within the MIPS; however, we have continued to hear 
from practices that challenges to participation in the Quality Payment 
Program still exist. Therefore, we believe it is appropriate to raise 
the low-volume threshold to not require these practices to participate 
in the program. However, we will review the impacts of this policy to 
determine if it should remain. We do not believe that raising the low-
volume threshold will cause quality disparities between urban and rural 
practices. With the increased low-volume threshold, additional 
practices will not be required to participate in the Quality Payment 
Program; however, we still encourage all clinicians to provide high-
value care to their patients. The goal of raising the low-volume 
threshold is to reduce burden on small practices, and we do not believe 
it will create a 2-tiered system. We appreciate the suggestion to study 
the impact on the rural health industry before finalizing this policy. 
We do not believe a study is necessary prior to finalizing this policy; 
rather, we believe that there is sufficient evidence from stakeholder 
feedback to reflect the value of increasing the low-volume threshold at 
this time. We do not agree that this policy would risk dismantling the 
EHR infrastructure. We believe that the low-volume threshold in Year 2 
provides MIPS eligible clinicians and groups, particularly those in 
smaller practices and rural areas, that do not exceed the low-volume 
threshold with additional time to further invest in their EHR 
infrastructure to gain experience in implementing and utilizing an EHR 
infrastructure to meet their needs and prepare for their potential 
participation in MIPS in future years while not being subject to the 
possibility of a negative payment adjustment. We believe that 
clinicians and patients benefit from the utilization and capabilities 
of an EHR infrastructure and would continue to utilize this technology. 
In addition, we do not believe we should delay implementation of this 
policy as it reduces the burden on individual MIPS eligible clinicians 
and those in small practices and in some rural areas. The intention of 
the Year 1 pick-your-pace policies were to set the foundation for MIPS 
to support long-term, high quality patient care through feedback by 
lowering the barriers to participation. Year 2 continues this 
transition as we are providing a gradual ramp-up of the program and of 
the performance thresholds. For the low-volume threshold, we are 
finalizing our proposal to increase the threshold, which excludes more 
eligible clinicians from MIPS. Specifically, we are finalizing our 
proposal to exclude an individual eligible clinician or group that, 
during the low-volume threshold determination period, has Medicare Part 
B allowed charges less than or equal to $90,000 or provides care for 
200 or fewer Part B-enrolled Medicare beneficiaries.
    Comment: Many commenters did not support the proposed low-volume 
threshold because it is based on the amount of Medicare billings from 
clinicians or number of beneficiaries. Instead, the commenters offered

[[Page 53591]]

recommendations for alternative ways of applying the low-volume 
threshold. Many commenters recommended that we exclude all practices 
with 15 or fewer clinicians. Several commenters recommended redefining 
the low-volume threshold so that it would mirror the policy for non-
patient facing eligible clinicians by excluding a group from MIPS if 75 
percent or more of its eligible clinicians individually fall below the 
low-volume threshold or if the group's average Medicare allowed charges 
or Medicare patient population falls below the threshold. The 
commenters noted that this would align status determinations across the 
Quality Payment Program and reduce complexity and burden. One commenter 
recommended excluding: Practices with less than $100,000 per clinician 
in Medicare charges not including Part B drug costs; practices with 10 
or fewer clinicians; and rural clinicians practicing in an area with 
fewer than 100 clinicians per 100,000 population. The commenter further 
encouraged us to consider excluding specialists who practice in ZIP 
codes or other geographic areas with low per capita numbers of 
clinicians in their specialty per population. One commenter recommended 
that we establish 2 different low-volume thresholds for primary care 
and specialty care clinicians. Another commenter recommended using a 
percentage of Medicare charges to total charges and a percentage of 
Medicare patients to total patients as opposed to the use of claims and 
patients. One commenter noted that the low-volume threshold's inclusion 
of beneficiaries creates an incentive for clinicians to turn away 
Medicare beneficiaries in order to fall below the low-volume threshold. 
Another commenter recommended that we exclude all clinicians who have 
elected to have non-participation status for Medicare. As an 
alternative to raising the low-volume threshold, one commenter 
recommended that we reduce the reporting requirement for small 
practices or for those practices between the previous threshold of 
$30,000 and 100 beneficiaries to $90,000 and 200 beneficiaries. Several 
commenters specifically did not support that a group could meet the 
low-volume threshold based on services provided by a small percentage 
of the clinicians in the group. A few commenters recommended that we 
exclude individuals who do not meet the low-volume threshold, even if 
the group practice otherwise met the low-volume threshold.
    Response: We note that some of the suggestions provided are not 
compliant with the statute, specifically, the suggestions on basing the 
low-volume threshold exclusion on practice size, practice location and 
specialty characteristics. We note that section 1848(q)(1)(C)(iv) of 
the Act requires the Secretary to select a low-volume threshold to 
apply for the purposes of this exclusion which may include one or more 
of the following: (1) The minimum number, as determined by the 
Secretary, of Part B-enrolled individuals who are treated by the 
eligible clinician for a particular performance period; (2) the minimum 
number, as determined by the Secretary, of items and services furnished 
to Part B-enrolled individuals by the eligible clinician for a 
particular performance period; and (3) the minimum amount, as 
determined by the Secretary, of allowed charges billed by the eligible 
clinician for a particular performance period. We do not believe the 
statute provides discretion in establishing exclusions other than the 
three exclusions specified above. Additionally, for the commenters 
suggestion to use a percentage of Medicare charges to total charges and 
a percentage of Medicare patients to total patients as opposed to the 
use of a minimum number of claims and patients, we will take this 
suggestion under consideration for future rulemaking. In regards to the 
commenters suggestion to exclude all clinicians from MIPS that have 
non-participation status within Medicare, we note that these clinicians 
may still fall within the definition of a MIPS eligible clinician at 
Sec.  414.1305. However, as provided in Sec.  414.1310(d), in no case 
will a MIPS payment adjustment apply to the items and services 
furnished during a year by clinicians who are not MIPS eligible 
clinicians.
    We note that the low-volume threshold is different from the other 
exclusions in that it is not determined solely based on the individual 
NPI status, it is based on both the TIN/NPI (to determine an exclusion 
at the individual level) and TIN (to determine an exclusion at the 
group level) status. In regard to group-level reporting, the group, as 
a whole, is assessed to determine if the group (TIN) exceeds the low-
volume threshold. Thus, eligible clinicians (TIN/NPI) who do not exceed 
the low-volume threshold at the individual reporting level and would 
otherwise be excluded from MIPS participation at the individual level, 
would be required to participate in MIPS at the group level if such 
eligible clinicians are part of a group reporting at the group level 
that exceeds the low-volume threshold. In the CY 2017 Quality Payment 
Program final rule (82 FR 77071) we considered aligning how MIPS 
exclusions would be applied at the group level. We recognized that 
alignment would provide a uniform application across exclusions and 
offer simplicity, but we also believed that it is critical to ensure 
that there are opportunities encouraging coordination, teamwork, and 
shared responsibility within groups. In order to encourage 
coordination, teamwork, and shared responsibility at the group level, 
we finalized that we would assess the low-volume threshold so that all 
clinicians within the group have the same status: all clinicians 
collectively exceed the low-volume threshold or they do not exceed the 
low-volume threshold. We appreciate the other concerns and 
recommendations provided by the commenters. We received a range of 
suggestions and considered the various options. We are finalizing our 
proposal to exclude an individual MIPS eligible clinician or group 
that, during the low-volume threshold determination period, has 
Medicare Part B allowed charges less than or equal to $90,000 or 
provides care for 200 or fewer Part B-enrolled Medicare beneficiaries. 
In this final rule with comment period, we are requesting additional 
comments regarding the application of low-volume threshold at the group 
level.
    Comment: Many commenters supported the proposed policy to provide 
clinicians the ability to opt-in to the MIPS if they meet or exceed 
one, but not all, of the low-volume threshold determinations, including 
as defined by dollar amount, beneficiary count, or, if established, 
items and services beginning with the 2019 MIPS performance period. 
Other commenters supported applying the opt-in based on the Medicare 
Part B charges criterion, but not the Medicare beneficiary criterion. 
Several commenters supported the proposal to allow opt-in but requested 
that the policy be retroactively applied to the 2017 MIPS performance 
period. A few commenters supported the proposed opt-in option but 
recommended that we establish separate performance benchmarks for 
excluded individuals or groups that opt-in. Other commenters 
recommended that we shield opt-in clinicians so that they can avoid a 
negative payment adjustment or other disadvantages of participation.
    Response: We appreciate the support of the proposed policy to 
provide clinicians the ability to opt-in to the MIPS if they meet or 
exceed one, but not all, of the low-volume threshold

[[Page 53592]]

determinations, including as defined by dollar amount, beneficiary 
count, or, if established, items and services beginning with the 2019 
MIPS performance period. However, we are not finalizing this proposal 
for the 2019 MIPS performance period. We are concerned that we will not 
be able to operationalize this policy in a low-burden manner to MIPS 
eligible clinicians as currently proposed. Specifically, our goal is to 
implement a process whereby a clinician can be made aware of their low-
volume threshold status and make an informed decision on whether they 
will participate in MIPS or not. We believe it is critical to implement 
a process that provides the least burden to clinicians in communicating 
this decision to us. Therefore, in this final rule with comment period, 
we are seeking additional comments on the best approach of implementing 
a low-volume threshold opt-in policy. As we plan to revisit this policy 
in the 2018 notice-and-comment rulemaking cycle. This additional time 
and additional public comments will give us the opportunity to explore 
how best to implement this policy and to perform additional analyses. 
We do not agree that we should allow any MIPS eligible clinicians that 
meet the low-volume threshold exclusion from any criterion to opt-in to 
MIPS, as it may impact our ability to create quality performance 
benchmarks that meet our sample size requirements. For example, if 
particularly small practices or solo practitioners with low Part B 
beneficiary volumes opt-in, such clinician's may lack sufficient sample 
size to be scored on many quality measures, especially measures that do 
not apply to all of a MIPS eligible clinician's patients. In addition, 
we do not believe MIPS eligible clinicians who opt-in should have 
different performance benchmarks nor avoid a negative payment 
adjustment. If the MIPS eligible clinician decides to opt-in, then they 
are committing to participating in the entire program, which would 
include being assessed on the same criteria as other MIPS eligible 
clinicians.
    Comment: A few commenters opposed the proposed policy to provide 
clinicians the ability to opt-in to the MIPS if they meet or exceed 
one, but not all, of the low-volume threshold determinations, including 
as defined by dollar amount, beneficiary count, or, if established, 
items and services beginning with the 2019 MIPS performance period. One 
commenter believed that an opt-in policy would complicate the program's 
ability to accurately evaluate clinician performance, which may result 
in unequal outcomes based on clinician participation at the individual- 
or group-level and specialty types. The commenter recommended that we 
fully evaluate the effect of the opt-in policy prior to implementing 
any changes.
    Response: We agree with the commenters' concerns and acknowledge 
that allowing an opt-in option may present additional complexity and 
could inadvertantly create a model where only high-performers opt-in. 
Therefore, we are not finalizing this proposal for the 2019 MIPS 
performance period. Rather, we are seeking further comment on the best 
approach to implementing the low-volume opt-in policy. This additional 
time will give us the opportunity to perform additional analyses. We 
intend to revisit this policy in the 2018 notice-and-comment rulemaking 
cycle.
    Comment: Several commenters supported the current low-volume 
threshold assessment period and proposal to use a 30-day claims run 
out. One commenter agreed with retaining the low-volume threshold 
status if triggered during the first 12-month determination period 
regardless of the status resulting from the second 12-month 
determination period. Another commenter did not support the use of a 
determination period for low-volume threshold that is outside of the 
performance period and believed that only data overlapping the 
performance period should be used to determine low-volume threshold 
status.
    Response: We appreciate the commenters' support of the low-volume 
threshold determination period and the proposed use of a 30-day claims 
run out. We believe that it is beneficial for MIPS eligible clinicians 
to know whether they are excluded under the low-volume threshold prior 
to the start of the performance period. In order to identify these MIPS 
eligible clinicians prior to the start of the performance period, we 
must use historical data that is outside of the performance period. We 
refer commenters to the CY 2017 Quality Payment Program final rule (82 
FR 77069 through 77070) for a full discussion of this policy.
    Final Action: After consideration of the public comments, we are 
finalizing our proposal to define at Sec.  414.1305 an individual 
eligible clinician or group that does not exceed the low-volume 
threshold as an individual eligible clinician or group that, during the 
low-volume threshold determination period, has Medicare Part B allowed 
charges less than or equal to $90,000 or provides care for 200 or fewer 
Part B-enrolled Medicare beneficiaries. In addition, for performance 
periods occurring in 2018 and future years, we are finalizing a 
modification to the low-volume threshold determination period, in which 
the initial 12-month segment of the low-volume threshold determination 
period would span from the last 4 months of a calendar year 2 years 
prior to the performance period followed by the first 8 months of the 
next calendar year and include a 30-day claims run out; and the second 
12-month segment of the low-volume threshold determination period would 
span from the last 4 months of a calendar year, 1 year prior to the 
performance period followed by the first 8 months of the performance 
period in the next calendar year and include a 30-day claims run out. 
In addition, in this final rule with comment period, we are seeking 
further comment on the best approach to implementing a low-volume 
threshold opt-in policy. We welcome suggestions on ways to implement 
the low-volume threshold opt-in that does not add additional burden to 
clinicians. We also are interested in receiving feedback on ways to 
mitigate our concern that only high-performers will choose to opt-in. 
We also are soliciting comment on whether our current application of 
the low-volume threshold to groups is still appropriate. We refer 
readers to the CY 2017 Quality Payment Program final rule (81 FR 77062 
through 77070) for a discussion on how the low-volume threshold is 
currently applied to groups.
3. Group Reporting
a. Background
    As discussed in the CY 2017 Quality Payment Program final rule, we 
established the following requirements for groups (81 FR 77072):
     Individual eligible clinicians and individual MIPS 
eligible clinicians will have their performance assessed as a group as 
part of a single TIN associated with two or more eligible clinicians 
(including at least one MIPS eligible clinician), as identified by an 
NPI, who have reassigned their Medicare billing rights to the TIN (at 
Sec.  414.1310(e)(1)).
     A group must meet the definition of a group at all times 
during the performance period for the MIPS payment year in order to 
have its performance assessed as a group (at Sec.  414.1310(e)(2)).
     Individual eligible clinicians and individual MIPS 
eligible clinicians within a group must aggregate their performance 
data across the TIN to have their performance assessed as a group (at 
Sec.  414.1310(e)(3)).

[[Page 53593]]

     A group that elects to have its performance assessed as a 
group will be assessed as a group across all four MIPS performance 
categories (at Sec.  414.1310(e)(4)).
    We stated in the CY 2017 Quality Payment Program final rule that 
groups attest to their group size for purpose of using the CMS Web 
Interface or identifying as a small practice (81 FR 77057). In section 
II.C.1.c. of this final rule with comment period, we are finalizing our 
proposal to modify the way in which we determine small practice size by 
establishing a process under which CMS would utilize claims data to 
make small practice size determinations. In addition, in section 
II.C.4.e. of this final rule comment period, we are finalizing our 
proposal to establish a policy under which CMS would utilize claims 
data to determine group size for groups of 10 or fewer eligible 
clinicians seeking to form or join a virtual group.
    As noted in the CY 2017 Quality Payment Program final rule, group 
size would be determined before exclusions are applied (81 FR 77057). 
We note that group size determinations are based on the number of NPIs 
associated with a TIN, which would include individual eligible 
clinicians (NPIs) who may be excluded from MIPS participation and do 
not meet the definition of a MIPS eligible clinician.
b. Registration
    As discussed in the CY 2017 Quality Payment Program final rule (81 
FR 77072 through 77073), we established the following policies:
     A group must adhere to an election process established and 
required by CMS (Sec.  414.1310(e)(5)), which includes:
    ++ Groups will not be required to register to have their 
performance assessed as a group except for groups submitting data on 
performance measures via participation in the CMS Web Interface or 
groups electing to report the CAHPS for MIPS survey for the quality 
performance category. For all other data submission mechanisms, groups 
must work with appropriate third party intermediaries as necessary to 
ensure the data submitted clearly indicates that the data represent a 
group submission rather than an individual submission.
    ++ In order for groups to elect participation via the CMS Web 
Interface or administration of the CAHPS for MIPS survey, such groups 
must register by June 30 of the applicable performance period (that is, 
June 30, 2018, for performance periods occurring in 2018). We note that 
groups participating in APMs that require APM Entities to report using 
the CMS Web Interface are not required to register for the CMS Web 
Interface or administer the CAHPS for MIPS survey separately from the 
APM.
    When groups submit data utilizing third party intermediaries, such 
as a qualified registry, QCDR, or EHR, we are able to obtain group 
information from the third party intermediary and discern whether the 
data submitted represents group submission or individual submission 
once the data are submitted.
    In the CY 2017 Quality Payment Program final rule (81 FR 77072 
through 77073), we discussed the implementation of a voluntary 
registration process if technically feasible. Since the publication of 
the CY 2017 Quality Payment Program final rule, we have determined that 
it is not technically feasible to develop and build a voluntary 
registration process. Until further notice, we are not implementing a 
voluntary registration process.
    Also, in the CY 2017 Quality Payment Program final rule (81 FR 
77075), we expressed our commitment to pursue the active engagement of 
stakeholders throughout the process of establishing and implementing 
virtual groups. Please refer to the CY 2018 Quality Payment Program 
proposed rule (82 FR 30027) for a full discussion of the public 
comments and additional stakeholder feedback we received in response to 
the CY 2017 Quality Payment Program final rule and additional 
stakeholder feedback gathered through hosting several virtual group 
listening sessions and convening user groups.
    As discussed in the CY 2018 Quality Payment Program proposed rule 
(82 FR 30027), one of the overarching themes we have heard is that we 
make an option available to groups that would allow a portion of a 
group to report as a separate subgroup on measures and activities that 
are more applicable to the subgroup and be assessed and scored 
accordingly based on the performance of the subgroup. In future 
rulemaking, we intend to explore the feasibility of establishing group-
related policies that would permit participation in MIPS at a subgroup 
level and create such functionality through a new identifier. 
Therefore, we solicited public comment on the ways in which 
participation in MIPS at the subgroup level could be established. In 
addition, in this final rule with comment period, we are seeking 
comment on additional ways to define a group, not solely based on a 
TIN. For example, redefining a group to allow for practice sites to be 
reflected and/or for specialties within a TIN to create groups.
    We received several comments on subgroup level policies and will 
take them into consideration for future rulemaking.
4. Virtual Groups
a. Background
    There are generally three ways to participate in MIPS: (1) 
Individual-level reporting; (2) group-level reporting; and (3) virtual 
group-level reporting. In the CY 2018 Quality Payment Program proposed 
rule (82 FR 30027 through 30034), we proposed to establish requirements 
for MIPS participation at the virtual group level.
    Section 1848(q)(5)(I) of the Act provides for the use of voluntary 
virtual groups for certain assessment purposes, including the election 
of certain practices to be a virtual group and the requirements for the 
election process. Section 1848(q)(5)(I)(i) of the Act provides that 
MIPS eligible clinicians electing to be a virtual group must: (1) Have 
their performance assessed for the quality and cost performance 
categories in a manner that applies the combined performance of all the 
MIPS eligible clinicians in the virtual group to each MIPS eligible 
clinician in the virtual group for the applicable performance period; 
and (2) be scored for the quality and cost performance categories based 
on such assessment for the applicable performance period. Section 
1848(q)(5)(I)(ii) of the Act requires the Secretary to establish and 
implement, in accordance with section 1848(q)(5)(I)(iii) of the Act, a 
process that allows an individual MIPS eligible clinician or a group 
consisting of not more than 10 MIPS eligible clinicians to elect, for a 
performance period, to be a virtual group with at least one other such 
individual MIPS eligible clinician or group. Virtual groups may be 
based on appropriate classifications of providers, such as by 
geographic areas or by provider specialties defined by nationally 
recognized specialty boards of certification or equivalent 
certification boards.
    Section 1848(q)(5)(I)(iii) of the Act provides that the virtual 
group election process must include the following requirements: (1) An 
individual MIPS eligible clinician or group electing to be in a virtual 
group must make their election prior to the start of the applicable 
performance period and cannot change their election during the 
performance period; (2) an individual MIPS eligible clinician or group 
may elect to be in no more than one virtual group for a performance 
period, and, in the case of a group, the election applies to all MIPS 
eligible clinicians in the

[[Page 53594]]

group; (3) a virtual group is a combination of TINs; (4) requirements 
providing for formal written agreements among individual MIPS eligible 
clinicians and groups electing to be a virtual group; and (5) such 
other requirements as the Secretary determines appropriate.
b. Definition of a Virtual Group
(1) Generally
    As noted above, section 1848(q)(5)(I)(ii) of the Act requires the 
Secretary to establish and implement, in accordance with section 
1848(q)(5)(I)(iii) of the Act, a process that allows an individual MIPS 
eligible clinician or group consisting of not more than 10 MIPS 
eligible clinicians to elect, for a performance period, to be a virtual 
group with at least one other such individual MIPS eligible clinician 
or group. Given that section 1848(q)(5)(I)(iii)(III) of the Act 
provides that a virtual group is a combination of TINs, we interpreted 
the references to an ``individual'' MIPS eligible clinician in section 
1848(q)(5)(I)(ii) of the Act to mean a solo practitioner, which, for 
purposes of section 1848(q)(5)(I) of the Act, we proposed to define as 
a MIPS eligible clinician (as defined at Sec.  414.1305) who bills 
under a TIN with no other NPIs billing under such TIN (82 FR 30027).
    Also, we recognized that a group (TIN) may include not only NPIs 
who meet the definition of a MIPS eligible clinician, but also NPIs who 
do not meet the definition of a MIPS eligible clinician at Sec.  
414.1305 or who are excluded from the definition of a MIPS eligible 
clinician under Sec.  414.1310(b) or (c). Thus, we interpreted the 
references to a group ``consisting of not more than 10'' MIPS eligible 
clinicians in section 1848(q)(5)(I)(ii) of the Act to mean a group with 
10 or fewer eligible clinicians (as such terms are defined at Sec.  
414.1305) (82 FR 30027). Under Sec.  414.1310(d), the MIPS payment 
adjustment would apply only to NPIs in the virtual group who meet the 
definition of a MIPS eligible clinician at Sec.  414.1305 and who are 
not excluded from the definition of a MIPS eligible clinician under 
Sec.  414.1310(b) or (c). We noted that groups must include at least 
one MIPS eligible clinician in order to meet the definition of a group 
at Sec.  414.1305 and thus be eligible to form or join a virtual group.
    We proposed to define a virtual group at Sec.  414.1305 as a 
combination of two or more TINs composed of a solo practitioner (that 
is, a MIPS eligible clinician (as defined at Sec.  414.1305) who bills 
under a TIN with no other NPIs billing under such TIN) or a group with 
10 or fewer eligible clinicians (as such terms are defined at Sec.  
414.1305) under the TIN that elects to form a virtual group with at 
least one other such solo practitioner or group for a performance 
period for a year (82 FR 30027 through 30028).
    With regard to the low-volume threshold, we recognized that such 
determinations are made at the individual and group level, but not at 
the virtual group level (82 FR 30031). For example, if an individual 
MIPS eligible clinician is part of a practice that is participating in 
MIPS (that is, reporting) at the individual level, then the low-volume 
threshold determination is made at the individual level. Whereas, if an 
individual MIPS eligible clinician is part of a practice that is 
participating in MIPS (that is, reporting) at the group level, then the 
low-volume threshold determination is made at the group level and would 
be applicable to such MIPS eligible clinician regardless of the low-
volume threshold determination made at the individual level. Similarly, 
if a solo practitioner or a group with 10 or fewer eligible clinicians 
seeks to participate in MIPS (that is, report) at the virtual group 
level, then the low-volume threshold determination made at the 
individual or group level, respectively, would be applicable to such 
solo practitioner or group. Thus, solo practitioners or groups with 10 
or fewer eligible clinicians that are determined not to exceed the low-
volume threshold at the individual or group level, respectively, would 
not be eligible to participate in MIPS as an individual, group, or 
virtual group, as applicable.
    Given that a virtual group must be a combination of TINs, we 
recognized that the composition of a virtual group could include, for 
example, one solo practitioner (NPI) who is practicing under multiple 
TINs (TIN A and TIN B), in which the solo practitioner would be able to 
form a virtual group with his or her own self based on each TIN 
assigned to the solo practitioner (TIN A/NPI and TIN B/NPI) (82 FR 
30032). As discussed in section II.C.4.b.(3) of this final rule with 
comment period, we did not propose to establish a limit on the number 
of TINs that may form a virtual group at this time.
    Lastly, we noted that qualification as a virtual group for purposes 
of MIPS does not change the application of the physician self-referral 
law to a financial relationship between a physician and an entity 
furnishing designated health services, nor does it change the need for 
such a financial relationship to comply with the physician self-
referral law (82 FR 30028).
    We refer readers to section II.C.4.b.(3) of this final rule with 
comment period for a summary of the public comments we received on 
these proposals and our responses.
(2) Application to Groups Containing Participants in a MIPS APM or an 
Advanced APM
    Additionally, we recognized that there are circumstances in which a 
TIN may have one portion of its NPIs participating under the generally 
applicable MIPS scoring criteria while the remaining portion of NPIs 
under the TIN is participating in a MIPS APM or an Advanced APM under 
the MIPS APM scoring standard (82 FR 30028). To clarify, for all 
groups, including those containing participants in a MIPS APM or an 
Advanced APM, the group's performance assessment will be based on the 
performance of the entire TIN. Generally, for groups other than those 
containing participants in a MIPS APM or an Advanced APM, each MIPS 
eligible clinician under the TIN (TIN/NPI) receives a MIPS adjustment 
based on the entire group's performance assessment (entire TIN). For 
groups containing participants in a MIPS APM or an Advanced APM, only 
the portion of the TIN that is being scored for MIPS according to the 
generally applicable scoring criteria (TIN/NPI) receives a MIPS 
adjustment based on the entire group's performance assessment (entire 
TIN). The remaining portion of the TIN that is being scored according 
to the APM scoring standard (TIN/NPI) receives a MIPS adjustment based 
on that standard. We noted that such participants may be excluded from 
MIPS if they achieve QP or Partial QP status. For more information, we 
refer readers to the CY 2017 Quality Payment Program final rule (81 FR 
77058, 77330 through 77331).
    We proposed to apply a similar policy to groups, including those 
containing participants in a MIPS APM or an Advanced APM, that are 
participating in MIPS as part of a virtual group (82 FR 30028). 
Specifically, for groups other than those containing participants in a 
MIPS APM or an Advanced APM, each MIPS eligible clinician under the TIN 
(TIN/NPI) would receive a MIPS adjustment based on the virtual group's 
combined performance assessment (combination of TINs). For groups 
containing participants in a MIPS APM or an Advanced APM, only the 
portion of the TIN that is being scored for MIPS according to the 
generally applicable scoring criteria (TIN/NPI) would receive a MIPS 
adjustment based on the virtual

[[Page 53595]]

group's combined performance assessment (combination of TINs). As 
discussed in section II.C.6.g. of this final rule with comment period, 
we proposed to use waiver authority to ensure that the remaining 
portion of the TIN that is being scored according to the APM scoring 
standard (TIN/NPI) would receive a MIPS adjustment based on that 
standard. We noted that such participants may be excluded from MIPS if 
they achieve QP or Partial QP status.
    We refer readers to section II.C.4.b.(3) of this final rule with 
comment period for a summary of the public comments we received on 
these proposals and our responses.
(3) Appropriate Classifications
    As noted above, the statute provides the Secretary with discretion 
to establish appropriate classifications regarding the composition of 
virtual groups, such as by geographic area or by specialty. We 
recognized that virtual groups would each have unique characteristics 
and varying patient populations. However, we believe it is important 
for virtual groups to have the flexibility to determine their own 
composition at this time, and, as a result, we did not propose to 
establish any such classifications regarding virtual group composition 
(82 FR 30028).
    We further noted that the statute does not limit the number of TINs 
that may form a virtual group, and we did not propose to establish such 
a limit at this time (82 FR 30028). We did consider proposing to 
establish such a limit, such as 50 or 100 participants. In particular, 
we were concerned that virtual groups of too substantial a size (for 
example, 10 percent of all MIPS eligible clinicians in a given 
specialty or sub-specialty) may make it difficult to compare 
performance between and among clinicians. We believe that limiting the 
number of virtual group participants could eventually assist virtual 
groups as they aggregate their performance data across the virtual 
group. However, we believe that as we initially implement virtual 
groups, it is important for virtual groups to have the flexibility to 
determine their own size, and thus, the better approach is not to place 
such a limit on virtual group size. We will monitor the ways in which 
solo practitioners and groups with 10 or fewer eligible clinicians form 
virtual groups and may propose to establish appropriate classifications 
regarding virtual group composition or a limit on the number of TINs 
that may form a virtual group in future rulemaking as necessary.
    We solicited public comment on these proposals, as well as our 
approach of not establishing appropriate classifications (such as by 
geographic area or by specialty) regarding virtual group composition or 
a limit on the number of TINs that may form a virtual group at this 
time.
    We noted that we received public comments in response to the CY 
2017 Quality Payment Program final rule and additional stakeholder 
feedback by hosting several virtual group listening sessions and 
convening user groups (82 FR 30028). We refer readers to the CY 2018 
Quality Payment Program proposed rule (82 FR 30027) for a summary of 
these comments and our response.
    The following is a summary of the public comments received 
regarding our proposals, as well as our approach of not establishing 
appropriate classifications (such as by geographic area or by 
specialty) regarding virtual group composition or a limit on the number 
of TINs that may form a virtual group at this time.
    Comment: A majority of commenters supported the concept of virtual 
groups, as defined, as a participation option available under MIPS.
    Response: We appreciate the support from the commenters.
    Comment: Several commenters did not support virtual groups being 
limited to groups consisting of not more than 10 eligible clinicians 
and requested that CMS expand virtual group participation to groups 
with more than 10 eligible clinicians.
    Response: As noted above, we interpreted the references to a group 
``consisting of not more than 10'' MIPS eligible clinicians in section 
1848(q)(5)(I)(ii) of the Act to mean a group with 10 or fewer eligible 
clinicians (as such terms are defined at Sec.  414.1305) (82 FR 30027). 
We do not have discretion to expand virtual group participation to 
groups with more than 10 MIPS eligible clinicians.
    Comment: One commenter recommended that CMS seek a technical 
amendment to section 1848(q)(5)(I) of the Act to replace the group 
eligibility threshold of 10 or fewer MIPS eligible clinicians with a 
patient population requirement of at least 5,000 to improve the 
validity of the reporting of virtual groups.
    Response: We appreciate the feedback from the commenter and will 
take the commenter's recommendation into consideration.
    Comment: A few commenters recommended that CMS allow a large, 
multispecialty group under one TIN to split into clinically relevant 
reporting groups, or allow multiple TINs within a health care delivery 
system to report as a virtual group.
    Response: In the CY 2017 Quality Payment Program final rule (81 FR 
77058), we noted that except for groups containing APM participants, we 
do not permit groups to ``split'' TINs if they choose to participate in 
MIPS as a group. As we considered the option of permitting groups to 
split TINs, we identified several issues that would make it challenging 
and cumbersome to implement a split TIN option such as the 
administrative burden of groups having to monitor and track which NPIs 
are reporting under which portion of a split TIN and the identification 
of appropriate criteria to be used for determining the ways in which 
groups would be able to split TINs (for example, based on specialty, 
practice site, location, health IT systems, or other factors). However, 
we recognize that there are certain advantages for allowing TINs to 
split, such as those the identified by the commenter. We intend to 
explore the option of permitting groups to split TINs, and any changes 
would be proposed in future rulemaking. Thus, we consider a group to 
mean an entire single TIN that elects to participate in MIPS at the 
group or virtual group level. However, for multiple TINs that are 
within a health care delivery system, such TINs would be able to form a 
virtual group provided that each TIN has 10 or fewer eligible 
clinicians.
    Comment: A significant portion of commenters expressed concern 
regarding the ineligibility of virtual group participation for solo 
practitioners and groups that do not exceed the low-volume threshold. 
The commenters noted that such solo practitioners and groups would not 
be able to benefit from participating as part of a virtual group and 
noted that the purpose of virtual group formation was to provide such 
solo practitioners and groups, which are otherwise unable to 
participate on their own, with an opportunity to join with other such 
entities and collectively become eligible to participate in MIPS as 
part of a virtual group. A few commenters recommended that the low-
volume threshold be conducted at the virtual group level.
    Response: In regard to stakeholder concerns pertaining to the low-
volume threshold eligibility determinations made at the individual and 
group level that would prevent certain solo practitioners and groups 
from being eligible to form a virtual group, we believe there are 
statutory constraints that do not allow us to establish a low-

[[Page 53596]]

volume threshold at the virtual group level. The statute includes 
specific references to ``MIPS eligible clinicians'' throughout the 
virtual group provisions, and we believe that such references were 
intended to limit virtual group participation to ``MIPS eligible 
clinicians'', that is, eligible clinicians who meet the definition of a 
MIPS eligible clinician and are not excluded under the low-volume 
threshold or any other statutory exclusion. As a result, we do not 
believe we are able to establish a low-volume threshold at the virtual 
group level because a solo practitioner or group would need to be 
considered eligible to participate in MIPS to form or join a virtual 
group.
    Comment: Many commenters supported the flexibility provided for 
virtual group composition, such as to not have parameters pertaining to 
geographic area, specialty, size, or other factors, while other 
commenters had concerns that such flexibility could circumvent bona 
fide clinical reasons for collaboration, incentivize practice 
consolidation, and cause an increase in costs without improving quality 
and health outcomes.
    Response: We appreciate the support from the commenters regarding 
the flexibility we are providing to virtual groups pertaining to 
composition. In regard to concerns from other commenters regarding such 
flexibility, we note that TINs vary in size, clinician composition, 
patient population, resources, technological capabilities, geographic 
area, and other characteristics, and may join or form virtual groups 
for various reasons, and we do not want to inhibit virtual group 
formation due to parameters. At this juncture of virtual group 
implementation, we believe that virtual groups should have the 
flexibility to determine their composition and size, and thus we do not 
want to limit the ways in which virtual groups are composed. However, 
we encourage TINs within virtual groups to assess means for promoting 
and enhancing the coordination of care and improving the quality of 
care and health outcomes. We will monitor the ways in which solo 
practitioners and groups with 10 or fewer eligible clinicians form 
virtual groups and may propose to establish appropriate classifications 
regarding virtual group composition or a limit on the number of TINs 
that may form a virtual group in future rulemaking as necessary.
    Comment: One commenter requested that CMS continue to examine the 
formation and implementation of virtual groups, ensuring equity and 
taking into account variability in patient case-mix and practice needs.
    Response: We appreciate the feedback from the commenter and will 
take the commenter's recommendation into consideration.
    Comment: One commenter indicated that the Quality Payment Program 
encourages eligible clinicians to aggregate data, share financial risk, 
and work together as virtual groups, which promotes joint 
accountability and creates delivery systems that are better able to 
improve the cost, quality, and experience of care. As a result, the 
commenter recommended that CMS issue detailed guidance and develop 
tools, resources, technical assistance, and other materials for 
guidance as to how clinicians can form virtual groups.
    Response: We appreciate the feedback from the commenter and note 
that we intend to publish a virtual group toolkit that provides 
information pertaining to requirements and outlines the steps a virtual 
group would pursue during the election process, which can be accessed 
on the CMS Web site at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/MACRA-MIPS-and-APMs.html.
    Comment: A few commenters recommended that only MIPS eligible 
clinicians be considered as part of a virtual group as written in the 
statute. The commenters indicated that CMS continues to include all 
eligible clinicians versus only MIPS eligible clinicians in the count 
to determine TIN size and requested that CMS instead rely on the ``not 
more than 10 MIPS eligible clinicians'' language in the statute, which 
would allow more groups to take advantage of the virtual group 
reporting option and focus more directly on the number of clinicians 
who are participating in and contributing to MIPS rather than 
clinicians who are excluded.
    Response: We note that our proposed definition of a virtual group 
reflects the statutory premise of virtual group participation 
pertaining to MIPS eligible clinicians. In the CY 2017 final rule (81 
FR 77539), we define a MIPS eligible clinician (identified by a unique 
billing TIN and NPI combination used to assess performance) at Sec.  
414.1305 to mean any of the following (excluding those identified at 
Sec.  414.1310(b)): (1) A physician as defined in section 1861(r) of 
the Act; (2) a physician assistant, a nurse practitioner, and clinical 
nurse specialist as such terms are defined in section 1861(aa)(5) of 
the Act; (3) a certified registered nurse anesthetist as defined in 
section 1861(bb)(2) of the Act; and (4) a group that includes such 
clinicians. The definition of a MIPS eligible clinician includes a 
group and we define a group at Sec.  414.1305 to mean a single TIN with 
two or more eligible clinicians (including at least one MIPS eligible 
clinician), as identified by their individual NPI, who have reassigned 
their billing rights to the TIN. Since a group is included under the 
definition of a MIPS eligible clinician, which would include two or 
more eligible clinicians (including at least one MIPS eligible 
clinician), our definition of a virtual group is consistent with 
statute.
    In regard to determining TIN size for purposes of virtual group 
eligibility, we count each NPI associated with a TIN in order to 
determine whether or not a TIN exceeds the threshold of 10 NPIs, which 
is an approach that we believe provides continuity over time if the 
definition of a MIPS eligible clinician is expanded in future years 
under section 1848(q)(1)(C)(i)(II) of the Act to include other eligible 
clinicians. We considered an alternative approach for determining TIN 
size, which would determine TIN size for virtual group eligibility 
based on NPIs who are MIPS eligible clinicians. However, as we 
conducted a comparative assessment of the application of such 
alternative approach with the current definition of a MIPS eligible 
clinician (as defined at Sec.  414.1305) and a potential expanded 
definition of a MIPS eligible clinician, we found that such an approach 
could create confusion as to which factors determine virtual group 
eligibility and cause the pool of virtual group eligible TINs to 
significantly be reduced once the definition of a MIPS eligible 
clinician would be expanded, which may impact a larger portion of 
virtual groups that intend to participate in MIPS as a virtual group 
for consecutive performance periods. Such impact would be the result of 
the current definition of a MIPS eligible clinician being narrower than 
the potential expanded definition of a MIPS eligible clinician. For 
example, under the recommended approach, a TIN with a total of 15 NPIs 
(10 MIPS eligible clinicians and 5 eligible clinicians) would not 
exceed the threshold of 10 MIPS eligible clinicians and would be 
eligible to participate in MIPS as a virtual group for the 2018 
performance period; however, if the definition of a MIPS eligible 
clinician were expanded through rulemaking for the 2019 performance 
period, such TIN, with no change in TIN size (15 NPIs), would exceed 
the threshold of 10 MIPS eligible clinicians if 1 or more of the 5 
eligible clinicians met the expanded definition

[[Page 53597]]

of a MIPS eligible clinician and no longer eligible to participate in 
MIPS as part of a virtual group. We did not pursue such an approach 
given that it did not align with our objective of establishing virtual 
group eligibility policies that are simplistic in understanding and 
provide continuity.
    Final Action: After consideration of the public comments received, 
we are finalizing with modification our proposal to define a solo 
practitioner at Sec.  414.1305 as a practice consisting of one eligible 
clinician (who is also a MIPS eligible clinician). We are also 
finalizing with modification our proposal to define a virtual group at 
Sec.  414.1305 as a combination of two or more TINs assigned to one or 
more solo practitioners or one or more groups consisting of 10 or fewer 
eligible clinicians, or both, that elect to form a virtual group for a 
performance period for a year. We are modifying the definition (i) to 
remove the redundant phrases ``with at least one other such solo 
practitioner or group'' and unnecessary parenthetical cross references; 
(ii) to accurately characterize TINs as being ``assigned to'' (rather 
than ``composed of'') a solo practitioner or group; and (iii) to 
clearly indicate that a virtual group can be composed of ``one or 
more'' solo practitioners or groups of 10 or fewer eligible clinicians. 
We note that we are modifying our proposed definitions for greater 
clarity and consistency with established MIPS terminology.
    We are also finalizing our proposal that for groups (TINs) that 
participate in MIPS as part of a virtual group and do not contain 
participants in a MIPS APM or an Advanced APM, each MIPS eligible 
clinician under the TIN (each TIN/NPI) will receive a MIPS payment 
adjustment based on the virtual group's combined performance assessment 
(combination of TINs). For groups (TINs) that participate in MIPS as 
part of a virtual group and contain participants in a MIPS APM or an 
Advanced APM, only the portion of the TIN that is being scored for MIPS 
according to the generally applicable scoring criteria will receive a 
MIPS adjustment based on the virtual group's combined performance 
assessment (combination of TINs). As discussed in section II.C.6.g. of 
this final rule with comment period, the remaining portion of the TIN 
that is being scored according to the APM scoring standard will receive 
a MIPS payment adjustment based on that standard. We note that such 
participants may be excluded from MIPS if they achieve QP or Partial QP 
status.
    At this juncture, we are not establishing additional 
classifications (such as by geographic area or by specialty) regarding 
virtual group composition or a limit on the number of TINs that may 
form a virtual group.
c. Virtual Group Identifier for Performance
    To ensure that we have accurately captured all of the MIPS eligible 
clinicians participating in a virtual group, we proposed that each MIPS 
eligible clinician who is part of a virtual group would be identified 
by a unique virtual group participant identifier (82 FR 30028 through 
30029). The unique virtual group participant identifier would be a 
combination of three identifiers: (1) Virtual group identifier 
(established by CMS; for example, XXXXXX); (2) TIN (9 numeric 
characters; for example, XXXXXXXXX); and (3) NPI (10 numeric 
characters; for example, 1111111111). For example, a virtual 
participant identifier could be VG-XXXXXX, TIN-XXXXXXXXX, NPI-
11111111111. We solicited public comment on this proposal.
    The following is a summary of the public comments received 
regarding our proposal.
    Comment: A majority of commenters expressed support for our 
proposal.
    Response: We appreciate the support from the commenters.
    Comment: One commenter indicated that a virtual group identifier 
would lead to administrative simplification and more accurate 
identification of MIPS eligible clinicians caring for Medicare 
beneficiaries, which could be used in recognizing and eliminating 
redundancies in the payer system.
    Response: We appreciate the support from the commenter. We believe 
that our proposed virtual group identifier will accurately identify 
each MIPS eligible clinician participating in a virtual group and be 
easily implemented by virtual groups.
    Comment: One commenter thanked CMS for not requiring virtual groups 
to form new TINs, which would add to the administrative burden for 
entities electing to become virtual groups, while another commenter 
requested clarification regarding whether or not members of a virtual 
group would need to submit a Reassignment of Benefits Form (CMS-855R) 
to the MAC and reassign their billing rights to the elected virtual 
group.
    Response: We note that a virtual group is recognized as an official 
collective entity for reporting purposes, but is not a distinct legal 
entity for billing purposes. As a result, a virtual group does not need 
to establish a new TIN for purposes of participation in MIPS, nor does 
any eligible clinician in the virtual group need to reassign their 
billing rights to a new or different TIN.
    Comment: A few commenters indicated that EHR developers need to 
know the specifications for the virtual group identifier as soon as 
technically feasible in order for such specifications to be included in 
their development efforts and implemented early in 2018. One commenter 
indicated that qualified registries submit data at the TIN level for 
group reporting and that individual NPI data is effectively obscured, 
and requested clarification regarding the type of information qualified 
registries would report for virtual groups, such as the virtual group 
identifier alone (VG-XXXXXX) or the combination of all three 
identifiers (VG-XXXXXX, TIN-XXXXXXXXX, NPI-11111111111).
    Response: For a virtual groups that are determined to have met the 
virtual group formation criteria and approved to participate in MIPS as 
an identified official virtual group, we will notify official 
designated virtual group representatives of their official virtual 
group status and issue a virtual group identifier. We intend to notify 
virtual groups of their official status as close to the start of the 
performance period as technically feasible. Virtual groups will need to 
provide their virtual group identifiers to the third party 
intermediaries that will be submitting their performance data, such as 
qualified registries, QCDRs, and/or EHRs. Qualified registries, QCDRs, 
and EHRs will include the virtual group identifier alone (VG-XXXXXX) in 
the file submissions. For virtual groups that elect to participate in 
MIPS via the CMS Web Interface or administer the CAHPS for MIPS survey, 
they will register via the CMS Web Interface and include the virtual 
group identifier alone (VG-XXXXXX) during registration. We intend to 
update submission specifications prior to the start of the applicable 
submission period.
    Comment: One commenter expressed concerns regarding the burden of 
using a virtual group identifier and the added administrative 
complexity to the claims process of using layered identifiers and 
modifiers. The commenter requested that CMS simplify the reporting 
process for MIPS eligible clinicians, groups, and virtual groups rather 
than increase the administrative burden.
    Response: We appreciate the feedback from the commenter. We do not 
believe that the virtual group identifier would be burdensome for 
virtual groups to implement. We believe that our proposed virtual group 
identifier is the most appropriate and simple approach,

[[Page 53598]]

which will allow for the accurate identification of each MIPS eligible 
clinician participating in a virtual group and be easily implemented by 
virtual groups.
    Final Action: After consideration of the public comments received, 
we are finalizing our proposal that each MIPS eligible clinician who is 
part of a virtual group will be identified by a unique virtual group 
participant identifier, which will be a combination of three 
identifiers: (1) Virtual group identifier (established by CMS; for 
example, XXXXXX); (2) TIN (9 numeric characters; for example, 
XXXXXXXXX); and (3) NPI (10 numeric characters; for example, 
1111111111). For example, a virtual group participant identifier could 
be VG-XXXXXX, TIN-XXXXXXXXX, NPI-11111111111.
d. Application of Group-Related Policies to Virtual Groups
(1) Generally
    In the CY 2017 Quality Payment Program final rule (81 FR 77070 
through 77072), we finalized various requirements for groups under MIPS 
at Sec.  414.1310(e), under which groups electing to report at the 
group level are assessed and scored across the TIN for all four 
performance categories. In the CY 2018 Quality Payment Program proposed 
rule (82 FR 30029), we proposed to apply our previously finalized and 
proposed group-related policies to virtual groups, unless otherwise 
specified. We recognized that there are instances in which we may need 
to clarify or modify the application of certain previously finalized or 
proposed group-related policies to virtual groups, such as the 
definition of a non-patient facing MIPS eligible clinician; small 
practice, rural area and HPSA designations; and groups that contain 
participants in a MIPS APM or an Advanced APM (see section II.C.4.b. of 
this final rule with comment period). More generally, such policies may 
include, but are not limited to, those that require a calculation of 
the number of NPIs across a TIN (given that a virtual group is a 
combination of TINs), the application of any virtual group 
participant's status or designation to the entire virtual group, and 
the applicability and availability of certain measures and activities 
to any virtual group participant and to the entire virtual group.
    We refer readers to section II.C.4.d.(5) of this final rule with 
comment period for a summary of the public comments we received on 
these proposals and our responses.
(2) Application of Non-Patient Facing Status to Virtual Groups
    With regard to the applicability of the non-patient facing MIPS 
eligible clinician-related policies to virtual groups, in the CY 2017 
Quality Payment Program final rule (81 FR 77048 through 77049), we 
defined the term non-patient facing MIPS eligible clinician at Sec.  
414.1305 as an individual MIPS eligible clinician that bills 100 or 
fewer patient facing encounters (including Medicare telehealth services 
defined in section 1834(m) of the Act) during the non-patient facing 
determination period, and a group provided that more than 75 percent of 
the NPIs billing under the group's TIN meet the definition of a non-
patient facing individual MIPS eligible clinician during the non-
patient facing determination period. In the CY 2018 Quality Payment 
Program proposed rule (82 FR 30021, 30029), we proposed to modify the 
definition of a non-patient facing MIPS eligible clinician to include 
clinicians in a virtual group, provided that more than 75 percent of 
the NPIs billing under the virtual group's TINs meet the definition of 
a non-patient facing individual MIPS eligible clinician during the non-
patient facing determination period. We noted that other policies 
previously established and proposed in the proposed rule for non-
patient facing groups would apply to virtual groups (82 FR 30029). For 
example, as discussed in section II.C.1.e. of this final rule with 
comment period, virtual groups determined to be non-patient facing 
would have their advancing care information performance category 
automatically reweighted to zero.
    We refer readers to section II.C.4.d.(5) of this final rule with 
comment period for a summary of the public comments we received on 
these proposals and our responses.
(3) Application of Small Practice Status to Virtual Groups
    With regard to the application of small practice status to virtual 
groups, in the CY 2017 Quality Payment Program final rule (81 FR 
77188), we defined the term small practices at Sec.  414.1305 as 
practices consisting of 15 or fewer clinicians and solo practitioners. 
In the CY 2018 Quality Payment Program proposed rule (82 FR 30019, 
30029), we proposed that a virtual group would be identified as a small 
practice if the virtual group does not have 16 or more eligible 
clinicians. In addition, we proposed for performance periods occurring 
in 2018 and future years to identify small practices by utilizing 
claims data; for performance periods occurring in 2018, we would 
identify small practices based on 12 months of data starting from 
September 1, 2016 to August 31, 2017 (82 FR 30019 through 30020). We 
refer readers to section II.C.1.c. of this final rule with comment 
period for the discussion of our proposal to identify small practices 
by utilizing claims data. We refer readers to section II.C.4.d.(3) of 
this final rule with comment period for the discussion regarding how 
small practice status would apply to virtual groups for scoring under 
MIPS.
    We refer readers to section II.C.4.d.(5) of this final rule with 
comment period for a summary of the public comments we received on our 
proposal to apply small practice status to virtual groups and our 
responses.
(4) Application of Rural Area and HSPA Practice Status to Virtual 
Groups
    In the CY 2018 Quality Payment Program proposed rule (82 FR 30020 
through 30021), we proposed to determine rural area and HPSA practice 
designations at the individual, group, and virtual group level. 
Specifically, for performance periods occurring in 2018 and future 
years, we proposed that an individual MIPS eligible clinician, a group, 
or a virtual group with multiple practices under its TIN or TINs within 
a virtual group would be designated as a rural area or HPSA practice if 
more than 75 percent of NPIs billing under the individual MIPS eligible 
clinician or group's TIN or within a virtual group, as applicable, are 
designated in a ZIP code as a rural area or HPSA. We noted that other 
policies previously established and proposed in the proposed rule for 
rural area and HPSA groups would apply to virtual groups (82 FR 30029). 
We note that in section II.C.7.b.(1)(b) of this final rule with comment 
period, we describe our scoring proposals for practices that are in a 
rural area.
    We refer readers to section II.C.4.d.(5) of this final rule with 
comment period for a summary of the public comments we received on 
these proposals and our responses.
(5) Applicability and Availability of Measures and Activities to 
Virtual Groups
    As noted above, we proposed to apply our previously finalized and 
proposed group-related policies to virtual groups, unless otherwise 
specified (82 FR 30029). In particular, we recognized that the measures 
and activities applicable and available to groups would also be 
applicable and available to virtual groups. Virtual groups would be 
required to meet the reporting

[[Page 53599]]

requirements for each measure and activity, and the virtual group would 
be responsible for ensuring that their measure and activity data are 
aggregated across the virtual group (for example, across their TINs). 
We noted that other previously finalized and proposed group-related 
policies pertaining to the four performance categories would apply to 
virtual groups.
    The following is a summary of the public comments received 
regarding our proposals.
    Comment: Many commenters supported our proposal to generally apply 
MIPS group-related policies to virtual groups, unless otherwise 
specified. The commenters indicated that such alignment would ease 
undue administrative and reporting burden.
    Response: We appreciate the support from the commenters.
    Comment: Several commenters supported our proposal to modify the 
definition of a non-patient facing MIPS eligible clinician to include 
clinicians in a virtual group provided that more than 75 percent of the 
NPIs billing under the virtual group's TINs meet the definition of a 
non-patient facing individual MIPS eligible clinician.
    Response: We appreciate the support from the commenters.
    Comment: One commenter expressed support for our proposal that a 
virtual group would be identified as a small practice if the virtual 
group does not have 16 or more eligible clinicians, while another 
commenter expressed support for our proposal that a virtual group with 
more than 75 percent of the NPIs billing under the virtual group's TINs 
are in a ZIP code designated as a rural area or HPSA would be 
designated as a rural area or HPSA practice at the virtual group level.
    Response: We appreciate the support from the commenters regarding 
our proposals.
    Comment: Several commenters did not support our proposal that a 
virtual group would be identified as a small practice if the virtual 
group does not have 16 or more eligible clinicians. The commenters 
expressed concerns that the benefits of forming a virtual group could 
be outweighed by the loss of the proposed small practice bonus points 
for virtual groups with more than 15 eligible clinicians, and that the 
elimination of small practice bonus points for such virtual groups 
would undermine the establishment of small practice policies afforded 
to such entities in statute. The commenters indicated that the 
formation of virtual groups would involve substantial administrative 
burdens for small practices, and that each TIN within a virtual group 
would otherwise qualify as a small practice and should not lose the 
accommodations to which they would otherwise be entitled. The 
commenters suggested that any virtual group, regardless of size, be 
considered a small practice. The commenters further stated that small 
practices that just slightly exceed the low-volume threshold may have 
the most challenges and difficulty succeeding in the Quality Payment 
Program.
    Response: We note that virtual groups with 15 or fewer eligible 
clinicians will continue to be considered a small practice as a 
collective entity. The small practice status is applied based on the 
collective entity as a whole and not based on the small practice status 
of each TIN within a virtual group. If a virtual group has 16 or more 
eligible clinicians, it would not be considered to have a small 
practice status as a collective whole. We believe that our approach is 
consistent with statute and not unfair to small practices that are a 
part of virtual groups with 16 or more eligible clinicians. Section 
1848(q)(2)(B)(iii) of the Act specifically refers to small practices of 
15 or fewer clinicians, and we do not believe it is appropriate to 
apply such designation to a virtual group as a collective single entity 
when a virtual group has 16 or more eligible clinicians. We encourage 
small practices to weigh the benefit of the special provisions specific 
to small practices against the benefits of virtual group participation 
when considering whether to form a virtual group that has 16 or more 
eligible clinicians. We refer readers to section II.C.7.b.(1)(c) of 
this final rule with comment for the discussion regarding the scoring 
of small practices. We want to ensure that small practices have the 
ability to determine the most appropriate means for participating in 
MIPS, whether it be as individuals, as a group or part of a virtual 
group. The formation of virtual groups provides for a comprehensive 
measurement of performance, shared responsibility, and an opportunity 
to effectively and efficiently coordinate resources to achieve 
requirements under each performance category. A small practice may 
elect to join a virtual group in order to potentially increase their 
performance under MIPS or elect to participate in MIPS as a group and 
take advantage of other flexibilities and benefits afforded to small 
practices. We note that if a virtual group has 16 or more eligible 
clinicians, it will not be considered a small practice.
    Comment: A few commenters did not support our proposal that a 
virtual group with more than 75 percent of the NPIs billing under the 
virtual group's TINs are in a ZIP code designated as a rural area or 
HPSA would be designated as a rural area or HPSA practice at the 
virtual group level. The commenters requested that CMS reduce the 
threshold pertaining to rural area and HPSA practice status for virtual 
groups and recommended that a virtual group with more than 50 percent 
of the NPIs billing under a virtual group's TINs are in a ZIP code 
designated as a rural area or HPSA would be designated as a rural area 
or HPSA practice at the virtual group level.
    Response: We disagree with the recommendation from the commenters. 
In order for a virtual group to be designated as a rural area or HPSA 
practice, we believe that a significant portion of a virtual group's 
NPIs would need to be in a ZIP code designated as a rural area or HPSA. 
Our proposal provides a balance between requiring more than half of a 
virtual group's NPIs to have such designations and requiring all NPIs 
within a virtual group to have such designations. Also, our proposed 
threshold pertaining to rural area and HPSA practice status for virtual 
groups aligns with other group-related and virtual group policies, 
which creates continuity among policies and makes virtual group 
implementation easier for TINs forming virtual groups.
    Comment: One commenter urged CMS to eliminate the all-cause 
hospital readmission measure from the quality performance category 
score for virtual groups with 16 or more eligible clinicians. The 
commenter noted that virtual groups would be newly formed and unlikely 
to have the same infrastructure and care coordination functionality 
that established groups under a single TIN may have in place, and that 
factoring the all-cause hospital readmission measure into their score 
would be inappropriate.
    Response: We recognize that small practices, including solo 
practitioners, would not be assessed on the all-cause hospital 
readmission measure as individual TINs. However, we believe that the 
all-cause hospital readmission measure is an appropriate measure, when 
applicable, to assess performance under the quality performance 
category of virtual groups with 16 or more eligible clinicians that 
meet the case volume of 200 cases. For virtual groups that do not meet 
the minimum case volume of 200, the all-cause hospital readmission 
measure would not be scored. Also, we believe that our approach for 
assessing performance based on the all-cause hospital readmission 
measure for virtual groups with 16 or more eligible clinicians is 
appropriate because it reflects the same

[[Page 53600]]

policy for groups, which was developed as a requirement to reduce 
burden (such measure is based on administrative claims data and does 
not require a separate submission of data) and ensure that we do not 
unfairly penalize MIPS eligible clinicians or groups that did not have 
adequate time to prepare adequately to succeed in the program while 
still rewarding high performers.
    Comment: One commenter supported our proposal to generally apply 
our group-related policies to virtual groups, specifically with regard 
to the improvement activities performance category requirements, under 
which groups and virtual groups would receive credit for an improvement 
activity as long as one NPI under the group's TIN or virtual group's 
TINs performs an improvement activity for a continuous 90-day period.
    Response: We appreciate the support from the commenter.
    Comment: One commenter requested clarification regarding how the 
proposed group-related policy that at least 50 percent of the practice 
sites within a TIN must be certified or recognized as a patient-
centered medical home or comparable specialty practice in order to 
receive full credit in the improvement activities performance category 
applies to virtual groups. Another commenter recommended that a virtual 
group receive full credit for the improvement activities performance 
category if at least 50 percent of its eligible clinicians are 
certified or recognized as a patient-centered medical home or 
comparable specialty practice.
    Response: As discussed in section II.C.7.a.(5)(c) of this final 
rule with comment period, in order for a group to receive full credit 
as a certified or recognized patient-centered medical home or 
comparable specialty practice under the improvement activities 
performance category, at least 50 percent of the practice sites within 
the TIN must be recognized as a patient-centered medical home or 
comparable specialty practice. In order for a virtual group to receive 
full credit as a certified or recognized patient-centered medical home 
or comparable specialty practice under the improvement activities 
performance category, at least 50 percent of the practice sites within 
the TINs that are part of a virtual group must be certified or 
recognized as a patient-centered medical home or comparable specialty 
practice.
    Comment: One commenter requested that CMS clarify how a virtual 
group would be expected to meet the advancing care information 
performance category requirements and whether all TINs within a virtual 
group would be required to have certified EHR technology.
    Response: In general and unless stated otherwise, for purposes of 
the advancing care information performance category, the policies 
pertaining to groups will apply to virtual groups. We refer readers to 
section II.C.6.f. of this final rule with comment period for more 
information on the generally applicable policies for the advancing care 
information performance category.
    We note that as with virtual group reporting for the other MIPS 
performance categories, to report as a virtual group, the virtual group 
will need to aggregate data for all of the individual MIPS eligible 
clinicians within the virtual group for which its TINs have data in 
CEHRT. For solo practitioners and groups that choose to report as a 
virtual group, performance on the advancing care information 
performance category objectives and measures will be reported and 
evaluated at the virtual group level. The virtual group will submit the 
data that its TINs have utilizing CEHRT and exclude data not collected 
from a non-certified EHR system. While we do not expect that every MIPS 
eligible clinician in a virtual group will have access to CEHRT, or 
that every measure will apply to every clinician in the virtual group, 
only those data contained in CEHRT should be reported for the advancing 
care information performance category.
    For example, the virtual group calculation of the numerators and 
denominators for each measure must reflect all of the data from the 
individual MIPS eligible clinicians (unless a clinician can be 
excluded) that have been captured in CEHRT for the given advancing care 
information performance category measure. If the groups (not including 
solo practitioners) that are part of a virtual group have CEHRT that is 
capable of supporting group level reporting, the virtual group would 
submit the aggregated data across the TINs produced by the CEHRT. If a 
group (TIN) that is part of a virtual group does not have CEHRT that is 
capable of supporting group level reporting, such group would aggregate 
the data by adding together the numerators and denominators for each 
MIPS eligible clinician within the group for whom the group has data 
captured in CEHRT. If an individual MIPS eligible clinician meets the 
criteria to exclude a measure, their data can be excluded from the 
calculation of that particular measure only.
    We recognize that it can be difficult to identify unique patients 
across a virtual group for the purposes of aggregating data on the 
advancing care information performance category measures, particularly 
when TINs within a virtual group may be using multiple CEHRT systems. 
For the 2018 performance period, TINs within virtual groups may be 
using systems which are certified to different CEHRT Editions. We 
consider ``unique patients'' to be individual patients treated by a TIN 
within a virtual group who would typically be counted as one patient in 
the denominator of an advancing care information performance category 
measure. This patient may see multiple MIPS eligible clinicians within 
a TIN that is part of a virtual group, or may see MIPS eligible 
clinicians at multiple practice sites of a TIN that is part of a 
virtual group. When aggregating performance on advancing care 
information measures for virtual group level reporting, we do not 
require that a virtual group determines that a patient seen by one MIPS 
eligible clinician (or at one location in the case of TINs working with 
multiple CEHRT systems) is not also seen by another MIPS eligible 
clinician in the TIN that is part of the virtual group or captured in a 
different CEHRT system. Virtual groups are provided with some 
flexibility as to the method for counting unique patients in the 
denominators to accommodate such scenarios where aggregation may be 
hindered by systems capabilities across multiple CEHRT platforms. We 
refer readers to section II.C.6.f.(4) of this final rule with comment 
for the discussion regarding certification requirements.
    Comment: One commenter requested that CMS require that a majority 
of eligible clinicians within a virtual group participate in activities 
to which the virtual group attests in the improvement activities and 
advancing care information performance categories in order for the 
virtual group to receive credit for those activities.
    Response: We note that a virtual group would need to meet the 
group-related requirements under each performance category. For the 
improvement activities performance category, a virtual group would meet 
the reporting requirements if at least one NPI within the virtual group 
completed an improvement activity for a minimum of a continuous 90-day 
period within CY 2018. In regard to the advancing care information 
performance category, a virtual group would need to fulfill the 
required base score measures for a minimum of 90 days in order to earn 
points for the advancing care information performance category. 
Additionally, virtual groups are able to submit performance score 
measures and bonus score measures in order to

[[Page 53601]]

increase the number of points earned under the advancing care 
information performance category.
    Comment: A few commenters requested that virtual groups have the 
same flexibility afforded to groups regarding the ability to report on 
different measures and utilize multiple submission mechanisms under 
each performance category.
    Response: We note that virtual groups will have the same 
flexibility as groups to report on measures and activities that are 
applicable and available to them. As discussed in section II.C.6.a.(1) 
of this final rule with comment period, the submission mechanisms 
available to groups under each performance category will also be 
available to virtual groups. Similarly, virtual groups will also have 
the same option as groups to utilize multiple submission mechanisms, 
but only one submission mechanism per performance category for the 2018 
performance period. However, starting with the 2019 performance period, 
groups and virtual groups will be able to utilize multiple submission 
mechanisms for each performance category.
    Comment: A few commenters recommended that CMS establish 
performance feedback for virtual groups and each TIN within a virtual 
group that includes complete performance data for each performance 
category. One commenter requested that CMS provide instructions 
regarding the appeal and audit process for virtual groups and TINs 
within a virtual group.
    Response: We note that performance feedback for virtual groups will 
be similar to feedback reports for groups, which is based on the 
performance of the entire group for each performance category. We note 
that virtual groups are required to aggregate their data across the 
virtual group, and will be assessed and scored at the virtual group 
level. Each TIN within the virtual group will receive feedback on their 
performance based on participation in MIPS as a virtual group, in which 
each TIN under the virtual group will have the same performance 
feedback applicable to the four performance categories. At this 
juncture, it is not technically feasible nor do we believe it is 
appropriate for us to de-aggregate data at the virtual group level and 
reassess performance data at the TIN or TIN/NPI level without requiring 
TINs and/or TIN/NPIs to submit data separately. We refer readers to 
section II.C.9.a. of this final rule with comment period for the 
discussion pertaining to performance feedback.
    Moreover, we note that virtual groups will have an opportunity to 
request a targeted review of their MIPS payment adjustment factor(s) 
for a performance period. In regard to an audit process, virtual groups 
would be subject to the MIPS data validation and auditing requirements 
as described in section II.C.9.c. of this final rule with comment 
period.
    Final Action: After consideration of public comments received, we 
are finalizing our proposal to apply our previously finalized and 
proposed group-related policies to virtual groups, unless otherwise 
specified.
    We are also finalizing our proposal to modify the definition of a 
non-patient facing MIPS eligible clinician at Sec.  414.1305 to include 
a virtual group, provided that more than 75 percent of the NPIs billing 
under the virtual group's TINs meet the definition of a non-patient 
facing individual MIPS eligible clinician during the non-patient facing 
determination period. Other previously finalized and proposed policies 
related to non-patient facing MIPS eligible clinicians would apply to 
such virtual groups.
    We are also finalizing our proposal that a virtual group will be 
considered a small practice if a virtual group consists of 15 or fewer 
eligible clinicians. Other previously finalized and proposed policies 
related to small practices would apply to such virtual groups.
    We are also finalizing our proposal that a virtual group will be 
designated as a rural area or HPSA practice if more than 75 percent of 
NPIs billing under the virtual group's TINs are designated in a ZIP 
code as a rural area or HPSA, the virtual group's TINs are designated 
as rural areas or HPSA practices. Other previously finalized and 
proposed policies related to rural area or HPSA practices would apply 
to such virtual groups.
    In response to public comments, we are also finalizing that a 
virtual group will be considered a certified or recognized patient-
centered medical home or comparable specialty practice under Sec.  
414.1380(b)(3)(iv) if at least 50 percent of the practices sites within 
the TINs are certified or recognized as a patient-centered medical home 
or comparable specialty practice.
e. Virtual Group Election Process
(1) Generally
    As noted in section II.C.4.a. of this final rule with comment 
period, section 1848(q)(5)(I)(iii)(I) and (II) of the Act provides that 
the virtual group election process must include certain requirements, 
including that: (1) An individual MIPS eligible clinician or group 
electing to be in a virtual group must make their election prior to the 
start of the applicable performance period and cannot change their 
election during the performance period; and (2) an individual MIPS 
eligible clinician or group may elect to be in no more than one virtual 
group for a performance period, and, in the case of a group, the 
election applies to all MIPS eligible clinicians in the group. 
Accordingly, we proposed to codify at Sec.  414.1315(a) that a solo 
practitioner (as defined at Sec.  414.1305) or group consisting of 10 
or fewer eligible clinicians (as such terms are defined at Sec.  
414.1305) electing to be in a virtual group must make their election 
prior to the start of the applicable performance period and cannot 
change their election during the performance period (82 FR 30029 
through 30030). Virtual group participants may elect to be in no more 
than one virtual group for a performance period, and, in the case of a 
group, the election applies to all MIPS eligible clinicians in the 
group.
    We noted that in the case of a TIN within a virtual group being 
acquired or merged with another TIN, or no longer operating as a TIN 
(for example, a group practice closes), during a performance period, 
such solo practitioner's or group's performance data would continue to 
be attributed to the virtual group (82 FR 30032). The remaining parties 
to the virtual group would continue to be part of the virtual group 
even if only one solo practitioner or group remains. We consider a TIN 
that is acquired or merged with another TIN, or no longer operating as 
a TIN (for example, a group practice closes), to mean a TIN that no 
longer exists or operates under the auspices of such TIN during a 
performance period.
    In order to provide support and reduce burden, we intend to make 
technical assistance (TA) available, to the extent feasible and 
appropriate, to support clinicians who choose to come together as a 
virtual group. Clinicians can access the TA infrastructure and 
resources that they may already be utilizing. For Quality Payment 
Program year 3, we intend to provide an electronic election process if 
technically feasible. We proposed that clinicians who do not elect to 
contact their designated TA representative would still have the option 
of contacting the Quality Payment Program Service Center to obtain 
information pertaining to virtual groups (82 FR 30030).
    We refer readers to section II.C.4.e.(3) of this final rule with 
comment period for a summary of the public comments we received on 
these proposals and our responses.

[[Page 53602]]

(2) Virtual Group Election Deadline
    For performance periods occurring in 2018 future years, we proposed 
to establish a virtual group election period (82 FR 30030). 
Specifically, we proposed to codify at Sec.  414.1315(a) that a solo 
practitioner (as defined at Sec.  414.1305) or group consisting of 10 
or fewer eligible clinicians (as such terms are defined at Sec.  
414.1305) electing to be in a virtual group must make their election by 
December 1 of the calendar year preceding the applicable performance 
period. A virtual group representative would be required to make the 
election, on behalf of the members of a virtual group, regarding the 
formation of a virtual group for the applicable performance period, by 
the election deadline. For example, a virtual group representative 
would need to make an election, on behalf of the members of a virtual 
group, by December 1, 2017 for the members of the virtual group to 
participate in MIPS as a virtual group during the CY 2018 performance 
period. We intend to publish the beginning date of the virtual group 
election period applicable to performance periods occurring in 2018 and 
future years in subregulatory guidance.
    We refer readers to section II.C.4.e.(3) of this final rule with 
comment period for a summary of the public comments we received on 
these proposals and our responses.
(3) Virtual Group Eligibility Determinations and Formation
    We proposed to codify at Sec.  414.1315(c) a two-stage virtual 
group election process, stage 1 of which is optional, for performance 
periods occurring in 2018 and 2019 (82 FR 30030 through 30032). Stage 1 
pertains to virtual group eligibility determinations, and stage 2 
pertains to virtual group formation. We noted that activity involved in 
stage 1 is not required, but a resource available to solo practitioners 
and groups with 10 or fewer eligible clinicians. Solo practitioners and 
groups that engage in stage 1 and are determined eligible for virtual 
group participation would proceed to stage 2; otherwise, solo 
practitioners and groups that do not engage in any activity during 
stage 1 would begin the election process at stage 2. Engaging in stage 
1 would provide solo practitioners and groups with the option to 
confirm whether or not they are eligible to join or form a virtual 
group before going to the lengths of executing formal written 
agreements, submitting a formal election registration, allocating 
resources for virtual group implementation, and other related 
activities; whereas, by engaging directly in stage 2 as an initial 
step, solo practitioners and groups might conduct all such efforts to 
only have their election registration be rejected with no recourse or 
remaining time to amend and resubmit.
    In stage 1, solo practitioners and groups with 10 or fewer eligible 
clinicians interested in forming or joining a virtual group would have 
the option to contact their designated TA representative in order to 
obtain information pertaining to virtual groups and/or determine 
whether or not they are eligible, as it relates to the practice size 
requirement of a solo practitioner or a group of 10 or fewer eligible 
clinicians, to participate in MIPS as a virtual group (Sec.  
414.1315(c)(1)(i)). During stage 1 of the virtual group election 
process, we would determine whether or not a TIN is eligible to form or 
join a virtual group. In order for a solo practitioner to be eligible 
to form or join a virtual group, the solo practitioner would need to 
meet the definition of a solo practitioner at Sec.  414.1305 and not be 
excluded from MIPS under Sec.  414.1310(b) or (c). In order for a group 
to be eligible to form or join a virtual group, a group would need to 
meet the definition of a group at Sec.  414.1305, have a TIN size that 
does not exceed 10 eligible clinicians, and not be excluded from MIPS 
under Sec.  414.1310(b) or (c). For purposes of determining TIN size 
for virtual group participation eligibility, we coined the term 
``virtual group eligibility determination period'' and defined it to 
mean an analysis of claims data during an assessment period of up to 5 
months that would begin on July 1 and end as late as November 30 of the 
calendar year prior to the applicable performance period and includes a 
30-day claims run out.
    To capture a real-time representation of TIN size, we proposed to 
analyze up to 5 months of claims data on a rolling basis, in which 
virtual group eligibility determinations for each TIN would be updated 
and made available monthly (82 FR 30030). We noted that an eligibility 
determination regarding TIN size is based on a relative point in time 
within the 5-month virtual group eligibility determination period, and 
not made at the end of such 5-month determination period.
    If at any time a TIN is determined to be eligible to participate in 
MIPS as part of a virtual group, the TIN would retain that status for 
the duration of the election period and the applicable performance 
period. TINs could determine their status by contacting their 
designated TA representative; otherwise, the TIN's status would be 
determined at the time that the TIN's virtual group election is 
submitted. For example, if a group contacted their designated TA 
representative on October 20, 2017, the claims data analysis would 
include the months of July through September of 2017, and, if 
determined not to exceed 10 eligible clinicians, the TIN's size would 
be determined at such time, and the TIN's eligibility status would be 
retained for the duration of the election period and the CY 2018 
performance period. If another group contacted their designated TA 
representative on November 20, 2017, the claims data analysis would 
include the months of July through October of 2017, and, if determined 
not to exceed 10 eligible clinicians, the TIN's size would be 
determined at such time, and the TIN's eligibility status would be 
retained for the duration of the election period and the CY 2018 
performance period.
    We believe such a virtual group determination period process 
provides a relative representation of real-time TIN size for purposes 
of virtual group eligibility and allows solo practitioners and groups 
to know their real-time eligibility status immediately and plan 
accordingly for virtual group implementation. It is anticipated that 
starting in September of each calendar year prior to the applicable 
performance period, solo practitioners and groups would be able to 
contact their designated TA representative and inquire about virtual 
group participation eligibility. We noted that TIN size determinations 
are based on the number of NPIs associated with a TIN, which would 
include clinicians (NPIs) who do not meet the definition of a MIPS 
eligible clinician at Sec.  414.1305 or who are excluded from MIPS 
under Sec.  414.1310(b) or (c).
    For groups that do not choose to participate in stage 1 of the 
election process (that is, the group does not request an eligibility 
determination), we will make an eligibility determination during stage 
2 of the election process. If a group began the election process at 
stage 2 and if its TIN size is determined not to exceed 10 eligible 
clinicians and not excluded based on the low-volume threshold exclusion 
at the group level, the group is determined eligible to participate in 
MIPS as part of a virtual group, and such virtual group eligibility 
determination status would be retained for the duration of the election 
period and applicable performance period. Stage 2 pertains to virtual 
group formation. For stage two, we proposed the following (82 FR 
30031):

[[Page 53603]]

     TINs comprising a virtual group must establish a written 
formal agreement between each member of a virtual group prior to an 
election (Sec.  414.1315(c)(2)(i)).
     On behalf of a virtual group, the official designated 
virtual group representative must submit an election by December 1 of 
the calendar year prior to the start of the applicable performance 
period (Sec.  414.1315(c)(2)(ii)). Such election will occur via email 
to the Quality Payment Program Service Center using the following email 
address for the 2018 and 2019 performance periods: 
[email protected].
     The submission of a virtual group election must include, 
at a minimum, information pertaining to each TIN and NPI associated 
with the virtual group and contact information for the virtual group 
representative (Sec.  414.1315(c)(2)(iii)). A virtual group 
representative would submit the following type of information: Each TIN 
associated with the virtual group; each NPI associated with a TIN that 
is part of the virtual group; name of the virtual group representative; 
affiliation of the virtual group representative to the virtual group; 
contact information for the virtual group representative; and 
confirmation through acknowledgment that a formal written agreement has 
been established between each member of the virtual group (solo 
practitioner or group) prior to election and each eligible clinician in 
the virtual group is aware of participating in MIPS as a virtual group 
for an applicable performance period. Each party to the virtual group 
agreement must retain a copy of the virtual group's written agreement. 
We noted that the virtual group agreement is subject to the MIPS data 
validation and auditing requirements as described in section II.C.9.c. 
of this final rule with comment period.
     Once an election is made, the virtual group representative 
must contact their designated CMS contact to update any election 
information that changed during an applicable performance period at 
least one time prior to the start of an applicable submission period 
(Sec.  414.1315(c)(2)(iv)). Virtual groups will use the Quality Payment 
Program Service Center as their designated CMS contact; however, we 
will define this further in subregulatory guidance.
    For stage 2 of the election process, we would review all submitted 
election information; confirm whether or not each TIN within a virtual 
group is eligible to participate in MIPS as part of a virtual group; 
identify the NPIs within each TIN participating in a virtual group that 
are excluded from MIPS in order to ensure that such NPIs would not 
receive a MIPS payment adjustment or, when applicable and when 
information is available, would receive a payment adjustment based on a 
MIPS APM scoring standard; calculate the low-volume threshold at the 
individual and group levels in order to determine whether or not a solo 
practitioner or group is eligible to participate in MIPS as part of a 
virtual group; and notify virtual groups as to whether or not they are 
considered official virtual groups for the applicable performance 
period. For virtual groups that are determined to have met the virtual 
group formation criteria and identified as an official virtual group 
participating in MIPS for an applicable performance period, we would 
contact the official designated virtual group representative via email 
notifying the virtual group of its official virtual group status and 
issuing a virtual group identifier for performance (as described in 
section II.C.4.c. of this final rule with comment period) that would 
accompany the virtual group's submission of performance data during the 
submission period.
    As we engaged in various discussions with stakeholders during the 
rulemaking process through listening sessions and user groups, 
stakeholders indicated that many solo practitioners and small groups 
have limited resources and technical capacities, which may make it 
difficult for the entities to form virtual groups without sufficient 
time and technical assistance. Depending on the resources and technical 
capacities of the entities, stakeholders conveyed that it may take 
entities 3 to 18 months to prepare to participate in MIPS as a virtual 
group. The majority of stakeholders indicated that virtual groups would 
need at least 6 to 12 months prior to the start of the CY 2018 
performance period to form virtual groups, prepare health IT systems, 
and train staff to be ready for the implementation of virtual group 
related activities by January 1, 2018.
    We recognized that for the first year of virtual group formation 
and implementation prior to the start of the CY 2018 performance 
period, the timeframe for virtual groups to make an election by 
registering would be relatively short, particularly from the date we 
issue the publication of a final rule toward the end of the 2017 
calendar year. To provide solo practitioners and groups with 10 or 
fewer eligible clinicians with additional time to assemble and 
coordinate resources, and form a virtual group prior to the start of 
the CY 2018 performance period, we provided virtual groups with an 
opportunity to make an election prior to the publication of our final 
rule. On October 11, 2017, the election period began and we issued 
information pertaining to the start date of the election process via 
subregulatory guidance, which can be accessed on the CMS Web site at 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/MACRA-MIPS-and-APMs.html. As discussed in section II.C.4.e. of this final rule with 
comment period, we are extending the virtual group election. Virtual 
groups would have from October 11, 2017 to December 31, 2017 to make an 
election for the 2018 performance year. However, any MIPS eligible 
clinicians applying to be a virtual group that does not meet all 
finalized virtual group requirements would not be permitted to 
participate in MIPS as a virtual group.
    As previously noted, solo practitioners and groups participating in 
a virtual group would have the size of their TIN determined for 
eligibility purposes. We recognized that the size of a TIN may 
fluctuate during a performance period with eligible clinicians and/or 
MIPS eligible clinicians joining or leaving a group. For solo 
practitioners and groups that are determined eligible to form or join a 
virtual group based on the one-time determination per applicable 
performance period, any new eligible clinicians or MIPS eligible 
clinicians that join the TIN during the performance period would 
participate in MIPS as part of the virtual group. In such cases, we 
recognized that a solo practitioner or group may exceed 1 eligible 
clinician or 10 eligible clinicians, as applicable, associated with its 
TIN during an applicable performance period, but such solo practitioner 
or group would have been determined eligible to form or join a virtual 
group given that the TIN did not have more than 1 eligible clinician or 
10 eligible clinicians, as applicable, associated with its TIN at the 
time of election. As previously noted, the virtual group representative 
would need to contact the Quality Payment Program Service Center to 
update the virtual group's information that was provided during the 
election period if any information changed during an applicable 
performance period at least one time prior to the start of an 
applicable submission period (for example, include new NPIs who joined 
a TIN that is part of a virtual group).

[[Page 53604]]

Virtual groups must re-register before each performance period.
    The following is a summary of the public comments received 
regarding our proposed election process for virtual groups.
    Comment: Generally, all commenters expressed support for the 
technical assistance infrastructure and two-stage election process.
    Response: We appreciate the support from commenters.
    Comment: A majority of commenters expressed concern regarding the 
election deadline of December 1, while several commenters recommended 
that an election deadline be established during the performance period 
in order for virtual groups to have the adequate and necessary time to 
prepare for the implementation of virtual groups, including the 
establishment and execution of formal written agreements and 
coordination within virtual groups to address issues pertaining to 
interoperability, measure selection, data collection and aggregation, 
measure specifications, workflows, resources, and other related items. 
A few commenters recommended an election deadline of June 30 to align 
with the election deadline for groups and virtual groups to register to 
use the CMS Web Interface and/or administer the CAHPS for MIPS survey.
    Response: We appreciate the feedback from commenters regarding the 
election deadline of December 1 and note that section 
1848(q)(5)(I)(iii)(I) of the Act provides that the virtual group 
election process must require an individual MIPS eligible clinician or 
group electing to be in a virtual group to make their election prior to 
the start of the applicable performance period. Given that the CY 
performance period for the quality and cost performance categories 
begins on January 1, a solo practitioner or group electing to be in a 
virtual group would need to make their election prior to January 1. As 
a result, we are modifying our proposed election deadline by extending 
it to December 31 of the calendar year preceding the applicable 
performance period. We note that our proposed election deadline of 
December 1 was intended to allow us to notify virtual groups of their 
official status prior to the start of the performance period. With the 
modification we are finalizing for the election deadline of December 
31, it is not operationally feasible for us to notify virtual groups of 
their official virtual group status prior to the start of the 
performance period. However, we intend to notify virtual groups of 
their official status as close to the start of the performance period 
as technically feasible.
    Comment: A few commenters indicated that solo practitioners and 
groups should have the option of leaving a virtual group during the 
performance period or allow a virtual group to remove a solo 
practitioner or group for non-compliance or low performance.
    Response: We note that the statute specifies that a virtual group 
election cannot be changed during the performance period, and such 
election would remain for the duration of the performance period.
    Comment: A few commenters requested that CMS allow virtual group 
agreements to be executed during the performance period in order to 
provide the virtual group parties with time to establish goals and 
objectives, build relationships with each other, and identify 
additional agreement provisions that may be necessary to include in 
order to meet program requirements.
    Response: We note that section 1848(q)(5)(I)(iii)(I) and (IV) of 
the Act provides that the virtual group election process must require 
an individual MIPS eligible clinician or group electing to be in a 
virtual group to make their election prior to the start of the 
applicable performance period, and include requirements providing for 
formal written agreements among individual MIPS eligible clinicians and 
groups electing to be a virtual group. Thus, we are not authorized to 
establish an agreement deadline during the performance period. However, 
we note that the parties to a virtual group agreement would not be 
precluded from amending their agreement during the performance period, 
which enables them to incorporate any additional agreement provisions 
that they later identify as necessary. A virtual group representative 
would notify CMS of the implementation and execution of an amended 
virtual group agreement.
    Final Action: After consideration of the public comments received, 
we are finalizing the following policies. We are codifying at Sec.  
414.1315(a) that a solo practitioner or a group of 10 or fewer eligible 
clinicians must make their election to participate in MIPS as a virtual 
group prior to the start of the applicable performance period and 
cannot change their election during the performance period; and 
codifying at Sec.  414.1315(c) a two-stage virtual group election 
process, stage 1 of which is optional, for the applicable 2018 and 2019 
performance periods. We are finalizing a modification to our proposed 
election period deadline by codifying at Sec.  414.1315(b) that, 
beginning with performance periods occurring in 2018, a solo 
practitioner, or group of 10 or fewer eligible clinicians electing to 
be in a virtual group must make their election by December 31 of the 
calendar year preceding the applicable performance period.
f. Virtual Group Agreements
    As noted in section II.C.4.a. of this final rule with comment 
period, section 1848(q)(5)(I)(iii)(IV) of the Act provides that the 
virtual group election process must provide for formal written 
agreements among individual MIPS eligible clinicians (solo 
practitioners) and groups electing to be a virtual group. We proposed 
that each virtual group member (that is, each solo practitioner or 
group) would be required to execute formal written agreements with each 
other virtual group member to ensure that requirements and expectations 
of participation in MIPS are clearly articulated, understood, and 
agreed upon (82 FR 30032 through 30033). We noted that a virtual group 
may not include a solo practitioner or group as part of the virtual 
group unless an authorized person of the TIN has executed a formal 
written agreement. During the election process and submission of a 
virtual group election, a designated virtual group representative would 
be required to confirm through acknowledgement that an agreement is in 
place between each member of the virtual group. An agreement would be 
executed for at least one performance period. If an NPI joins or leaves 
a TIN, or a change is made to a TIN that impacts the agreement itself, 
such as a legal business name change, during the applicable performance 
period, a virtual group would be required to update the agreement to 
reflect such changes and submit changes to CMS via the Quality Payment 
Program Service Center.
    We proposed, at Sec.  414.1315(c)(3), that a formal written 
agreement between each member of a virtual group must include the 
following elements:
     Expressly state the only parties to the agreement are the 
TINs and NPIs of the virtual group (at Sec.  414.1315(c)(3)(i)). For 
example, the agreement may not be between a virtual group and another 
entity, such as an independent practice association (IPA) or management 
company that in turn has an agreement with one or more TINs within the 
virtual group. Similarly, virtual groups should not use existing 
contracts between TINs that include third parties.
     Be executed on behalf of the TINs and the NPIs by 
individuals who are authorized to bind the TINs and the

[[Page 53605]]

NPIs, respectively at Sec.  414.1315(c)(3)(ii)).
     Expressly require each member of the virtual group 
(including each NPI under each TIN) to agree to participate in MIPS as 
a virtual group and comply with the requirements of the MIPS and all 
other applicable laws and regulations (including, but not limited to, 
federal criminal law, False Claims Act, anti-kickback statute, civil 
monetary penalties law, the Health Insurance Portability and 
Accountability Act of 1996, and physician self-referral law) (at Sec.  
414.1315(c)(3)(iii)).
     Require each TIN within a virtual group to notify all NPIs 
associated with the TIN of their participation in the MIPS as a virtual 
group (at Sec.  414.1315(c)(3)(iv)).
     Set forth the NPI's rights and obligations in, and 
representation by, the virtual group, including without limitation, the 
reporting requirements and how participation in MIPS as a virtual group 
affects the ability of the NPI to participate in the MIPS outside of 
the virtual group (at Sec.  414.1315(c)(3)(v)).
     Describe how the opportunity to receive payment 
adjustments will encourage each member of the virtual group (including 
each NPI under each TIN) to adhere to quality assurance and improvement 
(at Sec.  414.1315(c)(3)(vi)).
     Require each member of the virtual group to update its 
Medicare enrollment information, including the addition and deletion of 
NPIs billing through a TIN that is part of a virtual group, on a timely 
basis in accordance with Medicare program requirements and to notify 
the virtual group of any such changes within 30 days after the change 
(at Sec.  414.1315(c)(3)(vii)).
     Be for a term of at least one performance period as 
specified in the formal written agreement (at Sec.  
414.1315(c)(3)(viii)).
     Require completion of a close-out process upon termination 
or expiration of the agreement that requires the TIN (group part of the 
virtual group) or NPI (solo practitioner part of the virtual group) to 
furnish, in accordance with applicable privacy and security laws, all 
data necessary in order for the virtual group to aggregate its data 
across the virtual group (at Sec.  414.1315(c)(3)(ix)).
    On August 18, 2017, we published a 30-day Federal Register notice 
(82 FR 39440) announcing our formal submission of the information 
collection request (ICR) for the virtual group election process to OMB, 
which included a model formal written agreement, and informing the 
public on its additional opportunity to review the ICR and submit 
comments by September 18, 2017. OMB approved the ICR on September 27, 
2017 (OMB control number 0938-1343). The model formal written agreement 
is not required, but serves as a template that virtual groups could 
utilize in establishing an agreement with each member of a virtual 
group. Such agreement template will be made available via subregulatory 
guidance. Each prospective virtual group member should consult their 
own legal and other appropriate counsel as necessary in establishing 
the agreement.
    We want to ensure that all eligible clinicians who bill through the 
TINs that are components of a virtual group are aware of their 
participation in a virtual group. We want to implement an approach that 
considers a balance between the need to ensure that all eligible 
clinicians in a group are aware of their participation in a virtual 
group and the minimization of administration burden.
    We solicited public comment on these proposals and on approaches 
for virtual groups to ensure that all eligible clinicians in a group 
are aware of their participation in a virtual group.
    The following is a summary of the public comments received 
regarding our proposal to require formal written agreement between each 
member of a virtual group.
    Comment: Several commenters expressed support for the proposed 
provisions that virtual groups would need to include as part of the 
formal written agreement establishing a virtual group.
    Response: We appreciate the support from commenters.
    Comment: A few commenters expressed concern regarding the burden 
associated with the agreements required for virtual group 
implementation and execution. One commenter indicated that the formal 
written agreement process, while essential to allow for data capture, 
poses administrative burden and other complexities when utilizing 
multiple submission mechanisms.
    Response: We note that section 1848(q)(5)(I)(iii)(IV) of the Act 
provides that the virtual group election process must provide for 
``formal written agreements among MIPS eligible professionals'' (that 
is, individual MIPS eligible clinicians and groups) that elect to be a 
virtual group. As such, we do not believe that our proposal to require 
a written agreement governing the virtual group is excessively 
burdensome. However, although we believe the agreements should identify 
each eligible clinician billing under the TIN of a practice within the 
virtual group, we have concluded that it would be unnecessarily 
burdensome to require each such eligible clinician to be a party to the 
virtual group agreement. In addition, we agree that it is unnecessarily 
burdensome to require each solo practitioner or group that wishes to be 
part of a virtual group to have a separate agreement with every other 
solo practitioner or group that wishes to be part of the same virtual 
group. We do not believe the statute compels such a requirement; a 
single agreement among all solo practitioners and groups forming a 
virtual group is sufficient to implement the statutory requirement. 
Accordingly, we have revised the regulation text at Sec.  
414.1315(c)(3) to clarify that the parties to a formal written virtual 
group agreement must be only the groups and solo practitioners (as 
identified by name of party, TIN, and NPI) that compose the virtual 
group. We note that we are modifying our proposals for greater clarity.
    We recognize that our proposals regarding virtual group agreements 
as well as other virtual group matters used the term ``member of a 
virtual group'' inconsistently. In some places, we used the term to 
refer only to the components of the virtual group (that is, the solo 
practitioners and groups that can form a virtual group), while in other 
places we used the term to mean both the components of the virtual 
group and the eligible clinicians billing through a TIN that is a 
component of the virtual group. We believe that some of the perceived 
burden of the requirement for a virtual group agreement was due to the 
ambiguous use of this terminology. Wherever possible, we modified our 
proposals to ensure that they appropriately distinguishes between the 
components of a virtual group and the eligible clinicians billing 
through a TIN that is a component of a virtual group.
    Comment: One commenter expressed support for the proposed agreement 
provision that would require the parties to a virtual group agreement 
to be only solo practitioners and groups (not third parties), while 
another commenter did not support such provision and indicated that 
many small practices have joined IPAs to provide centralized support 
for quality improvement training, health technology support, reporting, 
and analytics needed for success under payment reform programs such as 
the Quality Payment Program. The commenter also indicated that IPAs 
could serve as the administrator of a virtual group by collecting and 
submitting data on behalf of the virtual group and requested that CMS 
eliminate the requirement for all members of a virtual group to execute 
a single joint agreement and expand the allowable

[[Page 53606]]

scope of the agreements by permitting IPAs to sign a virtual group 
agreement with each member of a virtual group.
    Response: For purposes of participation in MIPS as a virtual group, 
we note that eligible clinicians within a virtual group are 
collectively assessed and scored across each performance category based 
on applicable measures and activities that pertain to the performance 
of all TINs and NPIs within a virtual group. Each TIN and NPI within a 
virtual group has an integral role in improving quality of care and 
health outcomes, and increasing care coordination. As such, we believe 
it is appropriate prohibit third parties from becoming parties to a 
virtual group agreement. However, we note that virtual groups are not 
precluded from utilizing, or executing separate agreements with, third 
parties to provide support for virtual group implementation.
    Comment: To minimize the administrative burden, one commenter 
suggested that CMS not require all agreement requirements to be met in 
freestanding agreements. The commenter noted that the agreement could 
be an addendum to existing contracts to eliminate the need to draft an 
independent agreement, unless necessary.
    Response: We consider an ``existing'' contract to mean a contract 
that was established and executed prior to the formation of a virtual 
group. Depending on the parties to an existing contract, freestanding 
virtual group agreements may not be necessary. For example, if an 
existing contract was established between two or more TINs prior to the 
formation of a virtual group and such TINs formed a virtual group among 
themselves, the required provisions of a virtual group agreement could 
be included in the existing contract as an addendum as long as the 
parties to the existing contract include each TIN within the virtual 
group and all other requirements are satisfied prior to the applicable 
performance period. However, if the existing contract is with a third 
party intermediary or does not include each TIN within the virtual 
group, the virtual group agreement could not be effectuated as an 
addendum to the existing contract.
    We recognize that including virtual group agreement provisions as 
an addendum to an existing contract may reduce administrative burden 
and in certain circumstances such an addendum can be incorporated to an 
existing contract. However, we do believe it is critical that the 
inclusion of such provisions as an addendum does not limit or restrict 
the responsibility of each party to collectively meet the program 
requirements under MIPS. We reiterate that the statute requires formal 
written agreements to between each solo practitioner and group forming 
the virtual group. Individuals billing under the TIN of a party to a 
virtual group are collectively assessed and scored across each 
performance category based on applicable measures and activities that 
pertain to the performance of all TINs and NPIs within a virtual group. 
Each TIN and NPI within a virtual group has an integral role in 
improving quality of care and health outcomes, and increasing care 
coordination. As such, we believe it is appropriate to require 
agreements to only be between solo practitioners and groups and not 
include third parties. However, we note that virtual groups are not 
precluded from utilizing, or executing separate agreements with, third 
parties to provide support for virtual group implementation.
    Comment: One commenter requested that CMS clarify the parameters 
surrounding the proposed agreement provision that requires agreements 
to be executed on behalf of the TINs and the NPIs by individuals who 
are authorized to bind the TINs and the NPIs, and how CMS would 
evaluate the criterion in such provision when reviewing written 
agreements.
    Response: If a solo practitioner (or his or her professional 
corporation) is a party to a virtual group agreement, the solo 
practitioner could execute the agreement individually or on behalf of 
his or her professional corporation. We recognize that groups (TINs) 
have varying administrative and operational infrastructures. In 
general, one or more officers, agents, or other authorized individuals 
of a group would have the authority to legally bind the group. The 
parties to a virtual group agreement should ensure that the agreement 
is executed only by appropriately authorized individuals.
    Comment: One commenter expressed support for the proposed agreement 
provision that would require NPIs billing under a TIN in a virtual 
group to agree to participate in MIPS as a virtual group, and urged CMS 
to notify, by a means of direct communication, each NPI regarding his 
or her participation in MIPS as part of a virtual group prior to the 
performance period.
    Response: We appreciate the support from the commenter. We believe 
that it is critical for each eligible clinician in a virtual group to 
be aware of his or her participation in MIPS as part of a virtual 
group. Based on our experience under the Medicare Shared Savings 
Program, we found that NPIs continued to be unaware of their 
participation in a Medicare Shared Savings Program ACO regardless of 
the ACO's obligation to notify each NPI via direct communication. We 
considered directly notifying all NPIs regarding their participation in 
MIPS as part of a virtual group, but based on our experience under the 
Medicare Shared Savings Program, we do not believe that such action 
would be an effective way of ensuring that each NPI is aware of his or 
her TIN being part of a virtual group. We believe that communication 
within a TIN is imperative and the crux of ensuring that each NPI is 
aware of his or her participation in MIPS as part of a virtual group. 
As part of the virtual group election process, we will notify each 
virtual group representative regarding the official status of the 
virtual group. We will also require each TIN within a virtual group to 
notify all NPIs associated with the TIN of their participation in the 
MIPS as a virtual group.
    Comment: One commenter expressed support for one of the proposed 
agreement provisions that would set forth the NPI's rights and 
obligations in, and representation by, the virtual group. As part of 
the process for establishing an agreement, the commenter, as well as 
other commenters, requested that CMS allow virtual groups to discuss 
with all participants in the virtual group the ways in which the 
virtual group would meet the requirements for each performance 
category, the type of submission mechanism(s) the virtual group intends 
to utilize, the timelines for aggregating data across the TINs within 
the virtual group and for data submission, and the assessment and 
scoring of performance and application of the MIPS payment adjustment. 
Another commenter requested that the agreements include other elements 
such as requiring participation in improvement activities, use of EHR, 
and data sharing workflows, and suggested that CMS provide guidance on 
specific efficiencies and improvement goals that a virtual group could 
support and encourage virtual groups to create a plan for achieving 
those goals as a virtual group. A commenter suggested that the model 
agreement include provisions related to a mutual interest in quality 
performance, shared responsibility in decision making, a meaningful way 
to effectively use data to drive performance, and a mechanism to share 
best practices within the virtual group. Another commenter requested 
for CMS to develop a checklist for interested TINs to assist them in 
understanding the

[[Page 53607]]

requirements pertaining a virtual group agreement.
    Response: For the successful implementation of virtual groups, we 
believe that it is critical for everyone participating in a virtual 
group (including the individuals billing under the TIN of a group) to 
understand their rights and obligations in a virtual group. We believe 
that virtual groups should have the flexibility to identify additional 
requirements that would facilitate and guide a virtual group as it 
works to achieve its goals and meet program requirements. We note that 
the model agreement serves as a template that virtual groups could 
utilize in establishing a virtual group agreement, and could include 
other elements that would meet the needs of the virtual group to ensure 
that each TIN and NPI within a virtual group are collectively and 
collaboratively working together. We encourage the parties to a virtual 
group agreement to actively engage in discussions with eligible 
clinicians to develop a strategic plan, identify resources and needs, 
and establish processes, workflows, and other tools as they prepare for 
virtual group reporting. To support the efforts of solo practitioners 
and groups with 10 or fewer eligible clinicians in virtual group 
implementation, we intend to publish a virtual group toolkit that 
provides information pertaining to requirements and outlines the steps 
a virtual group would pursue during an the election process.
    Comment: One commenter requested that the agreement be a 1-year 
term and renewable thereafter.
    Response: We note that an agreement will need to be executed for at 
least one performance period. However, with virtual groups being 
required to be assessed and scored across all four performance 
categories, and the quality and cost performance categories having a 
calendar year performance period (at Sec.  414.1320), we clarify that a 
virtual group agreement would need to be executed for least a 1-year 
term. Virtual groups have the flexibility to establish a new agreement 
or renew the execution of an existing agreement for the preceding 
applicable performance period.
    Comment: One commenter requested that the virtual group agreements 
clearly specify the repercussions of an eligible clinician or group 
within a virtual group who fails to report as part of the virtual 
group.
    Response: We believe that the proposed provisions of a virtual 
group agreement provide a foundation that sets forth the 
responsibilities and obligations of each party for a performance 
period. Virtual groups have the flexibility to include other elements 
in an agreement. Each virtual group will be unique, and as a result, we 
encourage virtual groups to establish and execute an agreement that 
guides how a virtual group would meet its goals and objectives, and 
program requirements. Some virtual groups may elect to include a 
provision that outlines the implications of a solo practitioner or 
group failing to meet the elements of an agreement. We will also 
require such agreements to describe how the opportunity to receive 
payment adjustments will encourage each member of the virtual group 
(and each NPI under each TIN in the virtual group) to adhere to quality 
assurance and improvement.
    Comment: One commenter recommended that virtual group agreements 
contain similar elements used in agreements by the private sector, 
which would address factors pertaining to health IT and administrative 
and operationalization components such as: Requiring the establishment 
of a plan for integrating each virtual group component's health IT (for 
example, EHRs, patient registries, and practice management systems), 
including a timeline to work with health IT vendors on such 
integration, if applicable; requiring component of a virtual group to 
serve a common patient population and provide a list of hospitals and/
or facilities with which they have an affiliation and a list of 
counties in which they would be active; and determining how a virtual 
group would be staffed and governed by identifying staff allocations to 
organizational leadership, clinical leadership, practice consultants, 
and IT resources.
    Response: We recognize that different sectors may have established 
agreements with various elements to facilitate and assure attainment of 
program goals and objectives, which may serve as a useful tool to 
virtual groups. We encourage virtual groups to assess whether or not 
their agreement should include other elements in addition to our 
proposed agreement provisions. Virtual groups have the flexibility to 
identify other elements that would be critical to include in an 
agreement specific to their particular virtual group. We believe it is 
essential to continue to provide virtual groups with the flexibility to 
establish agreements that will most appropriately reflect the unique 
characteristics of a virtual group.
    Also, we note that different TINs, particularly small practices, 
may have access to different resources, which makes it difficult to 
identify specific requirements pertaining to the inclusion of 
administration and operationalization of health IT components in a 
virtual group agreement that would be universally applicable to any 
virtual group composition, while maintaining the flexibility and 
discretion afforded to virtual groups in establishing additional 
elements for their agreements that meet the needs of virtual groups. We 
recognize that each TIN within a virtual group will need to coordinate 
within the virtual group to address issues pertaining to 
interoperability, data collection, measure specifications, workflows, 
resources, and other related items, and believe that a virtual group is 
the most appropriate entity to determine how it will prepare, 
implement, and execute the functions of the virtual group to meet the 
requirements for each performance category. We believe that our 
proposed agreement elements provide a critical foundation for virtual 
group implementation, which establishes a clear responsibility and 
obligation of each NPI to the virtual group for the duration of an 
applicable performance period.
    Comment: Many commenters expressed concern regarding the timeframe 
virtual groups would have to make an election and establish agreements. 
The commenters indicated that the election period is very restrictive 
and does not provide interested solo practitioners and groups with 
sufficient time to meet and execute the required elements of an 
agreement and work through all of the necessary details in forming and 
implementing a virtual group. The commenters also noted that 
contractual agreements between NPIs and TINs often take several months, 
at least, to negotiate and finalize. A few commenters indicated that 
interested solo practitioners and groups would not have adequate time 
to make informed decisions regarding virtual group participation. The 
commenters noted that it would be helpful to have the virtual group 
agreement template available for review and comment in advance. One 
commenter indicated that the lack of virtual group requirements at this 
early stage of the Quality Payment Program causes a lack of clarity and 
stability for eligible clinicians and/or groups interested in forming 
virtual groups.
    Response: In order to provide support and reduce burden, we intend 
to make TA available, to the extent feasible and appropriate, to 
support clinicians who choose to come together as a virtual group. 
Clinicians can access the TA infrastructure and resources that they

[[Page 53608]]

may already be utilizing. In section II.C.4.e. of this final rule with 
comment period, we establish a two-stage virtual group election 
process, stage 1 of which is optional, for performance periods 
occurring in 2018 and 2019 (82 FR 30030 through 30032). Stage 1 
pertains to virtual group eligibility determinations, and stage 2 
pertains to virtual group formation. During stage 1, solo practitioners 
and groups have the option to contact their designated TA 
representative in order to obtain information pertaining to virtual 
groups and/or determine whether or not they are eligible, as it relates 
to the practice size requirement. Clinicians who do not elect to 
contact their designated TA representative would still have the option 
of contacting the Quality Payment Program Service Center to obtain 
information pertaining to virtual groups.
    We recognize that the election period, including the timeframe 
virtual groups would have to establish and implement the virtual group 
agreement, and the timeline for establishing virtual group policies in 
this final rule with comment period is short and imposes certain 
potential barriers for virtual group formation and limitations for the 
first year of virtual group implementation that we are not able to 
eliminate due to statutory constraints, such as the requirement for 
virtual groups to make an election made prior to an applicable 
performance period. In order to mitigate some of the challenges, we 
developed a model agreement to serve as a template that could be 
utilized by virtual groups as they prepare for the implementation of 
virtual groups and are finalizing a modification to the election period 
deadline by extending it to December 31, which can be accessed on the 
CMS Web site at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/MACRA-MIPS-and-APMs.html. In this final rule with comment period, 
we are establishing virtual group policies for the 2018 and 2019 
performance periods. Solo practitioners and groups with 10 or fewer 
eligible clinicians that are not able to form virtual groups for the 
2018 performance period should have sufficient time to prepare and 
implement requirements applicable to virtual groups for the 2019 
performance period.
    Comment: A majority of commenters indicated that virtual group 
formation involves preparing health IT systems, training staff to be 
ready for implementation, sharing and aggregating data, and 
coordinating workflows. The commenters expressed concern that while 
such steps are necessary to ensure the success of virtual groups, such 
steps could raise issues regarding compliance with certain fraud and 
abuse laws, particularly the physician self-referral law (section 1877 
of the Act) and the anti-kickback statute (section 1128B(b) of the 
Act). The commenters requested that CMS assess the potential risks 
virtual groups may have under the physician self-referral law and 
whether or not a regulatory exception would be necessary to 
successfully implement and maximize the advantages of the virtual group 
option. One commenter noted that parties to a virtual group agreement 
may want to enter into financial arrangements with each other to 
maximize the benefit of the virtual group (for example, pay for one 
party to organize and submit all measures on behalf of all the virtual 
group parties) and that such an arrangement may result in some eligible 
clinicians being unable to refer patients to other participants in the 
virtual group without running afoul of the physician self-referral law, 
unless CMS established an exception for virtual groups. A few 
commenters requested that the Secretary exercise prosecutorial 
discretion by not enforcing the anti-kickback statute and the physician 
self-referral law for activities involving the development and 
operation of a virtual group.
    Many commenters expressed concerns regarding the lack of 
information and clarity pertaining to the interaction between virtual 
groups and the physician self-referral law, anti-kickback statute, and 
antitrust law. The commenters requested that CMS clarify the program 
integrity obligations of virtual groups, issue safe harbors, and 
publish guidance outlining how the physician self-referral law, anti-
kickback statute, and antitrust law apply to virtual groups. The 
commenters asserted that this was needed in order for solo 
practitioners and groups to maintain safeguards against fraud and abuse 
while soliciting partners to form a virtual group and working toward 
common MIPS goals.
    Response: Nothing in this final rule with comment period changes 
the application of the physician self-referral law, anti-kickback 
statute, or anti-trust laws. We note that a ``group practice'' as 
defined for purposes of the physician self-referral law is separate and 
distinct from a ``virtual group'' as defined in this final rule. A 
virtual group may, but is not required, to include a ``group practice'' 
as defined for purposes of the physician self-referral law. Whether an 
entity that is assigned a TIN and is included in a virtual group should 
be a ``group practice'' (as defined for purposes of the physician self-
referral law) is a separate legal issue that is not governed by this 
final rule with comment period. We recognize that a virtual group may 
include multiple clinician practices and that the clinicians in one 
practice may refer patients for services that will be furnished by 
other practices in the virtual group. However, we believe that the 
virtual group arrangement can be structured in a manner that both 
complies with an existing physician self-referral law exception and 
does not violate the anti-kickback statute. We note that the issuance 
of guidance, exceptions, or safe harbors regarding the physician self-
referral law or the anti-kickback statute is beyond the scope of this 
rulemaking, and MACRA does not authorize the Secretary to waive any 
fraud and abuse laws for MIPS. Finally, HHS is not authorized to 
interpret or provide guidance regarding the anti-trust laws.
    Comment: Several commenters supported the development of a model 
agreement. One commenter indicated that the model agreement lacked the 
details necessary to enable virtual groups to cover all required 
criteria and urged CMS to supply a template that is inclusive of needed 
detail and instructions.
    Response: We appreciate the support from commenters. In regard to 
the model agreement, we established such a template in order to reduce 
the burden of virtual groups having to develop an agreement. On August 
18, 2017, we published a 30-day Federal Register notice (82 FR 39440) 
announcing our formal submission of the ICR for the virtual group 
election process to OMB, which included a model formal written 
agreement, and informing the public on its additional opportunity to 
review the information collection request and submit comments by 
September 18, 2017. OMB approved the ICR on September 27, 2017 (OMB 
control number 0938-1343). The utilization of our model agreement is 
not required, but serves as a tool that can be utilized by virtual 
groups. Each prospective party to a virtual group agreement should 
consult their own legal and other appropriate counsel as necessary in 
establishing the agreement. We note that the received comments 
pertaining to the content of the model agreement are out of scope for 
this final rule with comment period.
    Final Action: After consideration of public comments received, we 
are finalizing with modification our proposal at Sec.  414.1315(c)(3) 
regarding virtual group agreements. This final rule

[[Page 53609]]

with comment period requires a formal written agreement between each 
solo practitioner and group that composes a virtual group; the revised 
regulation text makes it clear the formal written virtual group 
agreement must identify, but need not include as parties to the 
agreement, all eligible clinicians who bill under the TINs that are 
components of the virtual group. The requirement to execute a formal 
written virtual group agreement ensures that requirements and 
expectations of participation in MIPS are clearly articulated, 
understood, and agreed upon. We are finalizing our proposal that a 
virtual group agreement must be executed on behalf of a party to the 
agreement by an individual who is authorized to bind the party. For 
greater clarity, we are finalizing with modification our proposals at 
Sec.  414.1315(c)(3) that a formal written agreement between each 
member of a virtual group must include the following elements:
     Identifies the parties to the agreement by name of party, 
TIN, and NPI, and includes as parties to the agreement only the groups 
and solo practitioners that compose the virtual group (at Sec.  
414.1315(c)(3)(i)).
     Is executed on behalf of each party by an individual who 
is authorized to bind the party (at Sec.  414.1315(c)(3)(ii)).
     Expressly requires each member of the virtual group (and 
each NPI under each TIN in the virtual group) to participate in MIPS as 
a virtual group and comply with the requirements of the MIPS and all 
other applicable laws and regulations (including, but not limited to, 
federal criminal law, False Claims Act, anti-kickback statute, civil 
monetary penalties law, the Health Insurance Portability and 
Accountability Act of 1996, and physician self-referral law) (at Sec.  
414.1315(c)(3)(iii)).
     Identifies each NPI under each TIN in the virtual group 
and requires each TIN within a virtual group to notify all NPIs 
associated with the TIN of their participation in the MIPS as a virtual 
group (at Sec.  414.1315(c)(3)(iv)).
     Sets forth the NPI's rights and obligations in, and 
representation by, the virtual group, including without limitation, the 
reporting requirements and how participation in MIPS as a virtual group 
affects the ability of the NPI to participate in the MIPS outside of 
the virtual group (at Sec.  414.1315(c)(3)(v)).
     Describes how the opportunity to receive payment 
adjustments will encourage each member of the virtual group (and each 
NPI under each TIN in the virtual group) to adhere to quality assurance 
and improvement (at Sec.  414.1315(c)(3)(vi)).
     Requires each party to the agreement to update its 
Medicare enrollment information, including the addition and deletion of 
NPIs billing through its TIN, on a timely basis in accordance with 
Medicare program requirements and to notify the virtual group of any 
such changes within 30 days after the change (at Sec.  
414.1315(c)(3)(vii)).
     Is for a term of at least one performance period as 
specified in the formal written agreement (at Sec.  
414.1315(c)(3)(viii)).
     Requires completion of a close-out process upon 
termination or expiration of the agreement that requires each party to 
the virtual group agreement to furnish, in accordance with applicable 
privacy and security laws, all data necessary in order for the virtual 
group to aggregate its data across the virtual group (at Sec.  
414.1315(c)(3)(ix)).
    During the election process and submission of a virtual group 
election, a designated virtual group representative will be required to 
confirm through acknowledgement that an agreement is in place between 
all solo practitioners and groups that compose the virtual group. An 
agreement will be executed for at least one performance period. If a 
NPI joins or leaves a TIN, or a change is made to a TIN that impacts 
the agreement itself, such as a legal business name change, during the 
applicable performance period, a virtual group will be required to 
update the agreement to reflect such changes and submit changes to CMS 
via the Quality Payment Program Service Center.
g. Virtual Group Reporting Requirements
    As discussed in section II.C.4.d. of this final rule with comment 
period, we believe virtual groups should generally be treated under the 
MIPS as groups. Therefore, for MIPS eligible clinicians participating 
at the virtual group level, we proposed at Sec.  414.1315(d) the 
following requirements (82 FR 30033):
     Individual eligible clinicians and individual MIPS 
eligible clinicians who are part of a TIN participating in MIPS at the 
virtual group level would have their performance assessed as a virtual 
group (at Sec.  414.1315(d)(1)).
     Individual eligible clinicians and individual MIPS 
eligible clinicians who are part of a TIN participating in MIPS at the 
virtual group level would need to meet the definition of a virtual 
group at all times during the performance period for the MIPS payment 
year (at Sec.  414.1315(d)(2)).
     Individual eligible clinicians and individual MIPS 
eligible clinicians who are part of a TIN participating in MIPS at the 
virtual group level must aggregate their performance data across 
multiple TINs in order for their performance to be assessed as a 
virtual group (at Sec.  414.1315(d)(3)).
     MIPS eligible clinicians that elect to participate in MIPS 
at the virtual group level would have their performance assessed at the 
virtual group level across all four MIPS performance categories (at 
Sec.  414.1315(d)(4)).
     Virtual groups would need to adhere to an election process 
established and required by CMS (at Sec.  414.1315(d)(5)).
    The following is a summary of the public comments received 
regarding our proposed virtual group reporting requirements.
    Comment: Many commenters generally supported our proposed reporting 
requirements for virtual groups.
    Response: We appreciate the support from the commenters.
    Comment: One commenter expressed support of our proposed virtual 
group reporting requirements and indicated that a majority of 
practicing vascular surgeons are part of private practices, including 
groups of 10 or fewer eligible clinicians, and would benefit from 
participating in MIPS as part of a virtual group. The commenter noted 
that the implementation of virtual groups would ease burdens on small 
practices and eligible clinicians by allowing them to report data 
together for each performance category, and be assessed and scored as a 
virtual group. Another commenter supported our proposal that allows 
small practices to aggregate their data at the virtual group level, 
which would allow them to have a larger denominator to spread risk and 
mitigate the impact of adverse outlier situations.
    Response: We appreciate the support from the comment regarding our 
proposed virtual group reporting requirements.
    Comment: One commenter indicated that the reporting of performance 
data for all NPIs under a TIN participating in a virtual group, 
particularly non-MIPS eligible clinicians who are excluded from MIPS 
participation, would be a regulatory burden to virtual groups.
    Response: We do not believe that requiring virtual groups to report 
on data for all NPIs under a TIN participating in a virtual group would 
be burdensome to virtual groups. Based on previous feedback from 
stakeholders regarding group reporting under PQRS, we believe that it 
would be more burdensome for virtual groups to

[[Page 53610]]

determine which clinicians are MIPS eligible versus not MIPS eligible 
and remove performance data for non-MIPS eligible clinicians when 
reporting as a virtual group. While entire TINs participate in a 
virtual group, including each NPI under a TIN, and are assessed and 
scored collectively as a virtual group, we note that only NPIs that 
meet the definition of a MIPS eligible clinician would be subject to a 
MIPS payment adjustment.
    Comment: A majority of commenters did not support our proposal to 
require all eligible clinicians who are part of a TIN participating in 
MIPS at the virtual group level to aggregate their performance data 
across multiple TINs in order for their performance to be assessed and 
scored as a virtual group. The commenters expressed concerns that it 
would be burdensome for rural and small practices and prohibitive for 
virtual groups to perform data aggregation and requested that CMS 
aggregate data for virtual groups. The commenters indicated that the 
requirement for virtual groups to aggregate data across the virtual 
group could be a potential barrier for virtual group participation and 
would be unlikely to occur without error. One commenter requested that 
CMS further define data aggregation and clarify whether or not 
individual reports from each NPI within a virtual group could simply be 
added together for all NPIs in the virtual group or if each NPI's data 
could be pulled from each TIN's QRDA file.
    Response: We appreciate the feedback from the commenters and 
recognize that data aggregation across multiple TINs within a virtual 
group may pose varying challenges. At this juncture, it is not 
technically feasible for us to aggregate the data for virtual groups, 
but will consider such option in future years. In order to support the 
implementation of virtual groups as a participation option under MIPS, 
we intend to issue subregulatory guidance pertaining to data 
aggregation for virtual groups.
    Comment: A few commenters recommended that for the first year of 
virtual group implementation, CMS hold virtual groups and registries 
that support virtual groups harmless from penalties if they encounter 
technical challenges related to data aggregation. The commenters noted 
that the potential penalty for technical challenges in data aggregation 
is a severe 5 percent for TINs that are already operating on small 
margins and expressed concerns that registries supporting virtual group 
reporting would be opening themselves to potential disqualification for 
the aforementioned challenges in data aggregation.
    Response: We appreciate the feedback from commenters and note that 
statute requires virtual groups to be assessed and scored, and subject 
to a MIPS payment adjustment as a result of TINs participating in a 
virtual group under MIPS. The statute does not authorize us to 
establish additional exclusions that are not otherwise identified in 
statute. If a virtual group encounters technical challenges regarding 
data aggregation and are not able to report on measures and activities 
via QCDRs, qualified registries, or EHRs, virtual groups would have the 
option of reporting via the CMS Web Interface (for virtual groups of 25 
or more eligible clinicians), a CMS-approved survey vendor for the 
CAHPS for MIPS survey, and administrative claims (if applicable) for 
the quality and cost performance categories, and via attestation for 
the improvement activities and advancing care information performance 
categories. The administrative claims submission mechanism does not 
require virtual groups to submit data for purposes of the quality and 
cost performance categories but the calculation of performance data is 
conducted by CMS.
    We note that the measure reporting requirements applicable to 
groups are also generally applicable to virtual groups. However, we 
note that the requirements for calculating measures and activities when 
reporting via QCDRs, qualified registries, EHRs, and attestation differ 
in their application to virtual groups. Specifically, these 
requirements apply cumulatively across all TINs in a virtual group. 
Thus, virtual groups will aggregate data for each NPI under each TIN 
within the virtual group by adding together the numerators and 
denominators and then cumulatively collate to report one measure ratio 
at the virtual group level. Moreover, if each MIPS eligible clinician 
within a virtual group faces a significant hardship or has EHR 
technology that has been decertified, the virtual group can apply for 
an exception to have its advancing care information performance 
category reweighted. If such exception application is approved, the 
virtual group's advancing care information performance category is 
reweighted to zero percent and applied to the quality performance 
category increasing the quality performance weight from 50 percent to 
75 percent.
    Additionally, the data submission criteria applicable to groups are 
also generally applicable to virtual groups. However, we note that data 
completeness and sampling requirements for the CMS Web Interface and 
CAHPS for MIPS survey differ in their application to virtual groups. 
Specifically, data completeness for virtual groups applies cumulatively 
across all TINs in a virtual group. Thus, we note that there may be a 
case when a virtual group has one TIN that falls below the 60 percent 
data completeness threshold, which is an acceptable case as long as the 
virtual group cumulatively exceeds such threshold. In regard to the CMS 
Web Interface and CAHPS for MIPS survey, sampling requirements pertain 
to Medicare Part B patients with respect to all TINs in a virtual 
group, where the sampling methodology would be conducted for each TIN 
within the virtual group and then cumulatively aggregated across the 
virtual group. A virtual group would need to meet the beneficiary 
sampling threshold cumulatively as a virtual group.
    Comment: A few commenters urged CMS to set clear expectations as to 
how virtual groups should submit data across performance categories and 
from multiple systems while ensuring their information is aggregated 
and reported correctly to maximize the virtual group's final score and 
requested that CMS provide clarity regarding virtual group reporting. 
One commenter indicated that virtual group reporting can be completed 
through QCDRs, in which multiple eligible clinicians in a virtual group 
could report to one place on the quality of care furnished to their 
respective patients. The commenter noted that the commitments from CMS 
and ONC regarding interoperability and electronic data sharing would 
continue to further the feasibility of virtual group reporting through 
EHRs in the future. However, a few commenters requested clarification 
regarding how data can and should be submitted for virtual groups, and 
whether or not QCDRs and other clinical outcomes data registries would 
be able to assist virtual groups by sharing in the responsibility for 
aggregating data. The commenters noted that the aggregation of data 
across various TINs and health IT systems may be logistically difficult 
and complex, as groups and health IT systems have different ways of 
collecting and storing data and stated that data aggregation across 
various systems for measures and activities under each performance 
category may not be possible if qualified registries do not have the 
option to assist virtual groups.
    Response: We appreciate the feedback from commenters and recognize 
that commenters seek clarification regarding submission requirements 
for third party intermediaries such as QCDRs, qualified registries, and 
EHRs. We note that third

[[Page 53611]]

party intermediaries would need to meet the same requirements 
established at Sec.  414.1400 and form and manner per submission 
mechanism when submitting data on behalf of virtual groups. We intend 
to issue subregulatory guidance for virtual groups and third party 
intermediaries pertaining to data aggregation and the collection and 
submission of data.
    Comment: One commenter requested clarification regarding the 
submission of data for virtual groups via EHRs. The commenter indicated 
that while groups may already be familiar with the reporting of quality 
measures via EHRs, the addition of the improvement activities and 
advancing care information performance categories adds a new level of 
complexity. Also, the commenter requested clarification regarding 
whether or not CMS has an established mechanism that would accept 
multiple QRDA III submissions for a single virtual group pertaining to 
the improvement activities and advancing care information performance 
categories. The commenter indicated that standards do not exist to 
combine files pertaining to the improvement activities and advancing 
care information performance categories from disparate vendors and 
requested clarification regarding whether or not combined files would 
be needed for virtual groups and for CMS to issue guidance to vendors 
at least 18 months in advance regarding development and implementation.
    Response: We appreciate the feedback from the commenter and note 
that we intend to issue additional subregulatory guidance for third 
party intermediaries pertaining to the collection and submission of 
data for all performance categories. In regard to the submission of 
multiple QRDA III files, our system is not built to allow for the 
submission of multiple QRDA III files. Groups and virtual groups are 
required to submit one QRDA III file for each performance category. 
Given that virtual groups are required to aggregate their data at the 
virtual level and submit one file of data per performance category, 
there may be circumstances that would require a virtual group to 
combine their files in order to meet the submission requirements. 
However, it should be noted that all other measures and activities 
requirements would also need to be met in order for virtual groups to 
meeting reporting and submission requirements.
    Comment: One commenter requested that CMS allow QCDRs and other 
clinical outcomes data registries to support virtual groups in 
aggregating measures and activities for reporting.
    Response: We note that virtual groups are not precluded from 
utilizing third party intermediaries such as QCDRs and qualified 
registries to support virtual groups in meeting virtual group reporting 
requirements. We intend to issue subregulatory guidance for virtual 
groups and third party intermediaries pertaining to data aggregation 
and the collection and submission of data.
    Comment: A few commenters expressed concern that the submission 
mechanisms available to virtual groups involve multiple layers of legal 
and operational complexity. The commenters indicated that certain 
registries have internal data governance standards, including patient 
safety organization requirements, that they must follow when 
contracting with single TIN participants, such that legal agreements 
made between solo practitioners and small groups within a virtual group 
may complicate the registries' ability to comply with those 
requirements. The commenters recommended that CMS provide guidance to 
registries on how to handle data sharing among virtual groups with 
respect to patient safety organization requirements. One commenter 
expressed concern regarding how registries would be able to meet 
virtual group requirements to report a sufficient number of measures 
given that some registries may have made a variety of measures 
available for individual eligible clinicians to report, but may need to 
increase the available measures to report in order to support virtual 
group reporting. The commenter requested that CMS provide guidance 
regarding the expectations for registries supporting virtual group 
reporting, particularly when considering the role of specialty 
registries and the quality performance category.
    Response: We recognize that certain registries may have internal 
governance standards complicating how they would support virtual 
groups, but note that by definition, a virtual group is a combination 
of TINs. We appreciate the feedback from commenters and note that we 
intend to issue additional subregulatory guidance for third party 
intermediaries such as qualified registries.
    Comment: One commenter expressed concern regarding how quality data 
would be collected, aggregated and displayed for solo practitioners and 
groups composing the virtual group. The commenter requested 
clarification regarding whether or not solo practitioners and groups 
composing the virtual group would be allowed to view the quality data 
of other solo practitioners and groups in the virtual group. Also, the 
commenter indicated that it is not clear what responsibility a 
qualified registry would have, if any, to verify if a virtual group 
reporting through a registry has all the appropriate legal agreements 
in place prior to their participation in the registry.
    Response: We appreciate the commenter expressing such concern and 
note that we intend to issue subregulatory guidance for virtual groups 
and third party intermediaries pertaining to data aggregation and the 
collection and submission of data. We note that the measure reporting 
requirements applicable to groups are also generally applicable to 
virtual groups. However, we note that the requirements for calculating 
measures and activities when reporting via QCDRs, qualified registries, 
EHRs, and attestation differ in their application to virtual groups. 
Specifically, these requirements apply cumulatively across all TINs in 
a virtual group. Thus, virtual groups will aggregate data for each NPI 
under each TIN within the virtual group by adding together the 
numerators and denominators and then cumulatively collate to report one 
measure ratio at the virtual group level. Moreover, if each MIPS 
eligible clinician within a virtual group faces a significant hardship 
or has EHR technology that has been decertified, the virtual group can 
apply for an exception to have its advancing care information 
performance category reweighted. If such exception application is 
approved, the virtual group's advancing care information performance 
category is reweighted to zero percent and applied to the quality 
performance category increasing the quality performance weight from 50 
percent to 75 percent.
    Additionally, the data submission criteria applicable to groups are 
also generally applicable to virtual groups. However, we note that data 
completeness and sampling requirements for the CMS Web Interface and 
CAHPS for MIPS survey differ in their application to virtual groups. 
Specifically, data completeness for virtual groups applies cumulatively 
across all TINs in a virtual group. Thus, we note that there may be a 
case when a virtual group has one TIN that falls below the 60 percent 
data completeness threshold, which is an acceptable case as long as the 
virtual group cumulatively exceeds such threshold. In regard to the CMS 
Web Interface and CAHPS for MIPS survey, sampling requirements pertain 
to Medicare Part B patients with respect to all TINs in a virtual 
group, where the sampling methodology would be conducted for

[[Page 53612]]

each TIN within the virtual group and then cumulatively aggregated 
across the virtual group. A virtual group would need to meet the 
beneficiary sampling threshold cumulatively as a virtual group. In 
regard to the comment requesting clarification on whether or not solo 
practitioners and groups composing a virtual group would be allowed to 
view quality data of other solo practitioners and groups in the virtual 
group, we note that virtual groups have the flexibility to determine 
if, how, and when solo practitioners and groups in the virtual group 
would be able to view quality data and/or data pertaining to the other 
three performance categories, in which such permissibility could be 
established as a provision under the virtual group agreement. Moreover, 
the establishment and execution of a virtual group agreement is the 
responsibility of the parties electing to participate in MIPS as part 
of a virtual group. Health IT vendors or third party intermediaries are 
not required to verify that each virtual group has established and 
executed a prior virtual group agreement.
    Comment: One commenter indicated that there would be added 
technical challenges for a virtual group representative when submitting 
on behalf of their virtual group given that he or she may face errors 
or warnings during submission and, due to the possibility that 
individual files could come from various EHR vendors, that 
representative would not have authority or the ability to work directly 
with another TIN's vendor.
    Response: We note that virtual groups have the flexibility to 
determine how they would complete reporting under MIPS. We believe that 
virtual groups would need to address operational elements to ensure 
that it would meet the reporting requirements for each performance 
category. Virtual groups are able to utilize the same multiple 
submission mechanisms that are available to groups. For the 2018 
performance period, groups and virtual groups can utilize multiple 
submission mechanism, but only use one submission mechanism per 
performance category. Starting with the 2019 performance period, groups 
and virtual groups will be able to utilize multiple submission 
mechanisms for each performance category.
    Comment: One commenter recommended that the virtual group 
infrastructure be defined and tested prior to implementation and noted 
that virtual group implementation does not appear to be ready for CY 
2018. Another commenter suggested that the virtual group reporting 
option have a transition year for the CY 2018 and CY 2019 performance 
periods in order for solo practitioners and groups to become familiar 
with implementing the virtual group reporting option as well as the 
election process and executing agreements. The commenter requested that 
virtual groups have the ``pick your pace'' options that were 
established for the CY 2017 performance period for the CY 2018 
performance period in order to test the virtual group option, whereby 
the virtual group would only need to report one quality measure or one 
improvement activity to avoid a negative MIPS payment adjustment.
    Response: We note that it is not permissible for virtual groups to 
meet the requirements established for the 2017 performance period given 
that such requirements are not applicable to the 2018 performance 
period. Moreover, the ``pick your pace'' options were based on the 
lower performance threshold established for the CY 2017 performance 
period. As discussed in section II.C.8.c. of this final rule with 
comment period, we are finalizing a higher performance threshold for 
the CY 2018 performance period, and the statute requires the 
establishment of one performance threshold for a performance period, 
which is the same for all MIPS eligible clinicians regardless of how or 
when they participate in MIPS. Year 2 requirements for virtual groups 
are defined throughout this final rule with comment period.
    Comment: One commenter requested that CMS require virtual groups to 
report a plan prior to the start of the performance period regarding 
how members of the virtual group (solo practitioners and groups) would 
share data internally, including how they would identify the measures 
that the virtual group would report, and share NPI-level performance 
data on those measures with each other during the performance period to 
facilitate performance improvement.
    Response: We appreciate the commenter recommending requirements for 
virtual groups, but disagree with the recommendation that would require 
virtual groups to submit a report to us prior to the start of the 
performance period outlining how the virtual group would share data 
internally, how the virtual group would identify the measures and 
activities to report, and share NPI-level performance data on those 
measures with each other during the performance period to facilitate 
performance improvement. We believe that the submission of such report 
prior to the start of the performance period would increase 
administrative burden for virtual groups. However, we encourage virtual 
groups to actively engage in discussions with its members to develop a 
strategic plan, select measures and activities to report, identify 
resources and needs, and establish processes, workflows, and other 
tools as they prepare for virtual group reporting. Virtual groups have 
the flexibility to identify other elements, in addition to our proposed 
agreement provisions, that would be critical to include in an agreement 
specific to their particular virtual group. We believe that virtual 
groups should have the flexibility to identify additional requirements 
that would facilitate and guide a virtual group as it works to achieve 
its goals and meet program requirements.
    Comment: One commenter recommended that CMS require all eligible 
clinicians within a virtual group to report on the same measure set. 
The commenter indicated that unifying measures would allow CMS to 
aggregate numerators and denominators more easily when calculating 
performance against measures.
    Response: For virtual groups that report via the CMS Web Interface, 
they would report on all measures within the CMS Web Interface. For 
virtual groups that report via other submission mechanisms, they would 
report on the same 6 measures for the quality performance category. We 
encourage virtual groups to assess the types of measures and measure 
sets to report to ensure that they would meet the reporting 
requirements for the applicable performance categories.
    Comment: One commenter recommended that CMS develop a web-based 
portal that would streamline reporting requirements for virtual groups. 
For example, CMS could model, to the extent possible and appropriate, a 
virtual group web-based portal on the CMS Web Interface. The 
availability of a web-based portal would relieve a substantial burden 
for solo practitioners and small groups who do not have the same level 
of resources as larger groups to purchase and maintain the 
infrastructure necessary for MIPS reporting. Moreover, the commenter 
indicated that a single reporting portal would ease data collection 
burden on CMS, enabling the Agency to collect and pull data from a 
single source under a single submission mechanism rather than engaging 
in a more cumbersome process that could require multiple data 
collection and submission mechanisms.
    Response: We have developed a web-based portal submission system 
that streamlines and simplifies the

[[Page 53613]]

submission of data at the individual, group, and virtual group level, 
including the utilization of multiple submission mechanisms (one 
submission mechanism per performance category), for each performance 
category. We will be issuing guidance at qpp.cms.gov pertaining to the 
utilization and functionality of such portal.
    Comment: Several commenters requested that CMS clarify whether or 
not data should be de-duplicated for virtual group reporting. The 
commenters indicated that TINs already have an issue of not being able 
to de-duplicate patient data across different health IT systems/
multiple EHRs. The commenters indicated that virtual groups need clear 
guidelines regarding how to achieve accurate reporting and suggested 
that CMS may want to consider delaying implementation of the virtual 
group reporting option until all related logistics issues and solutions 
are identified.
    Response: We interpret the commenter's reference to ``de-
duplicate'' to mean the identification of unique patients across a 
virtual group. We recognize that it may be difficult to identify unique 
patients across a virtual group for the purposes of aggregating 
performance on the advancing care information measures, particularly 
when a virtual group is using multiple CEHRT systems. For 2018, virtual 
groups may be using systems which are certified to different CEHRT 
editions further adding to this challenge. We consider ``unique 
patients'' to be individual patients treated by a TIN within a virtual 
group who would typically be counted as one patient in the denominator 
of an advancing care information measure. This patient may see multiple 
MIPS eligible clinicians within a TIN that is part of a virtual group, 
or may see MIPS eligible clinicians at multiple practice sites of a TIN 
that is part of a virtual group. When aggregating performance on 
advancing care information measures for virtual group level reporting, 
we do not require that a virtual group determine that a patient seen by 
one MIPS eligible clinician (or at one location in the case of TINs 
working with multiple CEHRT systems) is not also seen by another MIPS 
eligible clinician in the TIN that is part of the virtual group or 
captured in a different CEHRT system.
    In regard to the suggestion provided by the commenter regarding the 
delay of the implementation of virtual groups, we are not able to 
further postpone the implementation of virtual groups. We recognize 
that there are various elements and factors that virtual groups would 
need to address prior to the execution of virtual groups. Also, we 
recognize that certain solo practitioners and groups may not be ready 
to form virtual groups for the 2018 performance period.
    Comment: One commenter expressed concern regarding how a health IT 
vendor would support a virtual group regardless of submission 
mechanism, CEHRT, registry, and/or billing claims. The commenter 
indicated that having multiple health IT vendors and products to 
support within a single virtual group would complicate the ability to 
aggregate data for a final score, affect the productivity of the health 
IT vendor in its effort to support the virtual groups, and increase 
coding and billing errors.
    Response: We note that virtual groups may elect to utilize health 
IT vendors and/or third party intermediaries for the collection and 
submission of data on behalf of virtual groups. As discussed in section 
II.C.6.a.(1) of this final rule with comment period, the submission 
mechanisms available to groups under each performance category will 
also be available to virtual groups. Similarly, virtual groups will 
also have the same option as groups to utilize multiple submission 
mechanisms, but only one submission mechanism per performance category 
for the 2018 performance period. However, starting with the 2019 
performance period, groups and virtual groups will be able to utilize 
multiple submission mechanisms for each performance category. We 
believe that our policies pertaining to the availability and 
utilization of multiple submission mechanisms increases flexibility and 
reduces burden. However, we recognize that data aggregation across at 
the virtual group level may pose varying challenges.
    We note that the measure reporting requirements applicable to 
groups are also generally applicable to virtual groups. However, we 
note that the requirements for calculating measures and activities when 
reporting via QCDRs, qualified registries, EHRs, and attestation differ 
in their application to virtual groups. Specifically, these 
requirements apply cumulatively across all TINs in a virtual group. 
Thus, virtual groups will aggregate data for each NPI under each TIN 
within the virtual group by adding together the numerators and 
denominators and then cumulatively collate to report one measure ratio 
at the virtual group level. Moreover, if each MIPS eligible clinician 
within a virtual group faces a significant hardship or has EHR 
technology that has been decertified, the virtual group can apply for 
an exception to have its advancing care information performance 
category reweighted. If such exception application is approved, the 
virtual group's advancing care information performance category is 
reweighted to zero percent and applied to the quality performance 
category increasing the quality performance weight from 50 percent to 
75 percent.
    Additionally, the data submission criteria applicable to groups are 
also generally applicable to virtual groups. However, we note that data 
completeness and sampling requirements for the CMS Web Interface and 
CAHPS for MIPS survey differ in their application to virtual groups. 
Specifically, data completeness for virtual groups applies cumulatively 
across all TINs in a virtual group. Thus, we note that there may be a 
case when a virtual group has one TIN that falls below the 60 percent 
data completeness threshold, which is an acceptable case as long as the 
virtual group cumulatively exceeds such threshold. In regard to the CMS 
Web Interface and CAHPS for MIPS survey, sampling requirements pertain 
to Medicare Part B patients with respect to all TINs in a virtual 
group, where the sampling methodology would be conducted for each TIN 
within the virtual group and then cumulatively aggregated across the 
virtual group. A virtual group would need to meet the beneficiary 
sampling threshold cumulatively as a virtual group.
    Final Action: After consideration of the public comments received, 
we are finalizing the following virtual group reporting requirements:
     Individual eligible clinicians and individual MIPS 
eligible clinicians who are part of a TIN participating in MIPS at the 
virtual group level will have their performance assessed as a virtual 
group at Sec.  414.1315(d)(1).
     Individual eligible clinicians and individual MIPS 
eligible clinicians who are part of a TIN participating in MIPS at the 
virtual group level will need to meet the definition of a virtual group 
at all times during the performance period for the MIPS payment year 
(at Sec.  414.1315(d)(2)).
     Individual eligible clinicians and individual MIPS 
eligible clinicians who are part of a TIN participating in MIPS at the 
virtual group level must aggregate their performance data across 
multiple TINs in order for their performance to be assessed as a 
virtual group (at Sec.  414.1315(d)(3)).
     MIPS eligible clinicians that elect to participate in MIPS 
at the virtual group level will have their performance assessed at the 
virtual group level across all four MIPS performance categories (at 
Sec.  414.1315(d)(4)).

[[Page 53614]]

     Virtual groups will need to adhere to an election process 
established and required by CMS (at Sec.  414.1315(d)(5)).
h. Virtual Group Assessment and Scoring
    As noted in section II.C.4.a. of this final rule with comment 
period, section 1848(q)(5)(I)(i) of the Act provides that MIPS eligible 
clinicians electing to be a virtual group must: (1) Have their 
performance assessed for the quality and cost performance categories in 
a manner that applies the combined performance of all the MIPS eligible 
clinicians in the virtual group to each MIPS eligible clinician in the 
virtual group for the applicable performance period; and (2) be scored 
for the quality and cost performance categories based on such 
assessment for the applicable performance period. We believe it is 
critical for virtual groups to be assessed and scored at the virtual 
group level for all performance categories, as it eliminates the burden 
of virtual group components having to report as a virtual group and 
separately outside of a virtual group. Additionally, we believe that 
the assessment and scoring at the virtual group level provides for a 
comprehensive measurement of performance, shared responsibility, and an 
opportunity to effectively and efficiently coordinate resources to also 
achieve performance under the improvement activities and the advancing 
care information performance categories. Therefore, we proposed at 
Sec.  414.1315(d)(4) that virtual groups would be assessed and scored 
across all four MIPS performance categories at the virtual group level 
for a performance period for a year (82 FR 30033 through 30034).
    In the CY 2017 Quality Payment Program final rule (81 FR 77319 
through 77329), we established the MIPS final score methodology at 
Sec.  414.1380, which would apply to virtual groups. We refer readers 
to sections II.C.4.h. and II.C.6.g. of this final rule with comment 
period for scoring policies that would apply to virtual groups.
    As noted in section II.C.4.g. of this final rule with comment 
period, we proposed to allow solo practitioners and groups with 10 or 
fewer eligible clinicians that have elected to be part of a virtual 
group to have their performance measured and aggregated at the virtual 
group level across all four performance categories; however, we would 
apply payment adjustments at the individual TIN/NPI level. Each TIN/NPI 
would receive a final score based on the virtual group performance, but 
the payment adjustment would still be applied at the TIN/NPI level. We 
would assign the virtual group score to all TIN/NPIs billing under a 
TIN in the virtual group during the performance period.
    During the performance period, we recognized that NPIs in a TIN 
that has joined a virtual group may also be participants in an APM. The 
TIN, as part of the virtual group, would be required to submit 
performance data for all eligible clinicians associated with the TIN, 
including those participating in APMs, to ensure that all eligible 
clinicians associated with the TIN are being measured under MIPS.
    APMs seek to deliver better care at lower cost and to test new ways 
of paying for care and measuring and assessing performance. In the CY 
2017 Quality Payment Program final rule, we established policies to the 
address concerns we have expressed in regard to the application of 
certain MIPS policies to MIPS eligible clinicians in MIPS APMs (81 FR 
77246 through 77269). In the CY 2018 Quality Payment Program proposed 
rule, we reiterated those concerns and proposed additional policies for 
the APM scoring standard (82 FR 30080 through 30091). We believe it is 
important to consistently apply the APM scoring standard under MIPS for 
eligible clinicians participating in MIPS APMs in order to avoid 
potential misalignments between the evaluation of performance under the 
terms of the MIPS APM and evaluation of performance on measures and 
activities under MIPS, and to preserve the integrity of the initiatives 
we are testing. Therefore, we believe it is necessary to waive the 
requirement to only use the virtual group scores under section 
1848(q)(5)(I)(i)(II) of the Act, and instead to apply the score under 
the APM scoring standard for eligible clinicians in virtual groups who 
are also in an APM Entity participating in an APM.
    Specifically, for participants in MIPS APMs, we proposed to use our 
authority under section 1115A(d)(1) of the Act for MIPS APMs authorized 
under section 1115A of the Act, and under section 1899(f) of the Act 
for the Shared Savings Program, to waive the requirement under section 
1848(q)(2)(5)(I)(i)(II) of the Act that requires performance category 
scores from virtual group reporting to be used to generate the final 
score upon which the MIPS payment adjustment is based for all TIN/NPIs 
in the virtual group. Instead, we would use the score assigned to the 
MIPS eligible clinician based on the applicable APM Entity score to 
determine MIPS payment adjustments for all MIPS eligible clinicians 
that are part of an APM Entity participating in a MIPS APM, in 
accordance with Sec.  414.1370, instead of determining MIPS payment 
adjustments for these MIPS eligible clinicians using the final score of 
their virtual group.
    We noted that MIPS eligible clinicians who are participants in both 
a virtual group and a MIPS APM would be assessed under MIPS as part of 
the virtual group and under the APM scoring standard as part of an APM 
Entity group, but would receive their payment adjustment based only on 
the APM Entity score. In the case of an eligible clinician 
participating in both a virtual group and an Advanced APM who has 
achieved QP status, the clinician would be assessed under MIPS as part 
of the virtual group, but would still be excluded from the MIPS payment 
adjustment as a result of his or her QP status. We refer readers to 
section II.C.6.g. of this final rule with comment period for further 
discussion regarding the waiver.
    The following is a summary of the public comments received 
regarding our proposals.
    Comment: Many commenters supported our proposals regarding the 
assessment and scoring of virtual group performance and the application 
of the MIPS payment adjustment to MIPS eligible clinicians based on the 
virtual group's final score.
    Response: We appreciate the support from the commenters.
    Comment: One commenter supported our proposal to assess and score 
virtual groups at the virtual group level and indicated that such an 
approach would provide comprehensive measurement, shared responsibility 
and coordination of resources, and reduce burden. Another commenter 
expressed support for requiring the aggregation of data across the TINs 
within a virtual group, including the performance data of APM 
participants, to assess the performance of a virtual group given that 
it would be difficult for TINs to separate and exclude data for some 
NPIs. One commenter supported our proposal to utilize waiver authority, 
which allows MIPS eligible clinicians within a virtual group to receive 
their MIPS payment adjustment based on the virtual group score while 
allowing APM participants who are also a part of a virtual group to 
receive their MIPS payment adjustment based on their APM Entity score 
under the APM scoring standard.
    Response: We appreciate the support from the commenters regarding 
our proposals.
    Comment: One commenter requested clarification regarding whether or 
not the MIPS payment adjustment would only apply to MIPS eligible 
clinicians within a virtual group.

[[Page 53615]]

    Response: We note that each eligible clinician in a virtual group 
will receive a virtual group score that is reflective of the combined 
performance of a virtual group; however, only MIPS eligible clinicians 
will receive a MIPS payment adjustment based on the virtual group final 
score. In the case of an eligible clinician participating in both a 
virtual group and an Advanced APM who has achieved QP status, such 
eligible clinician will be assessed under MIPS as part of the virtual 
group, but will still be excluded from the MIPS payment adjustment as a 
result of his or her QP status. Conversely, in the case of an eligible 
clinician participating in both a virtual group and an Advanced APM who 
has achieved Partial QP status, it is recognized that such eligible 
clinician would be excluded from the MIPS payment adjustment unless 
such eligible clinician elects to report under MIPS. We note that 
affirmatively agreeing to participate in MIPS as part of a virtual 
group prior to the start of the applicable performance period would 
constitute an explicit election to report under MIPS. Thus, eligible 
clinicians who participate in a virtual group and achieve Partial QP 
status would remain subject to the MIPS payment adjustment due to their 
election to report under MIPS. New Medicare-enrolled eligible 
clinicians and clinician types not included in the definition of a MIPS 
eligible clinician who are associated with a TIN that is part of a 
virtual group would receive a virtual group score, but would not 
receive a MIPS payment adjustment. MIPS eligible clinicians who are 
participants in both a virtual group and a MIPS APM will be assessed 
under MIPS as part of the virtual group and under the APM scoring 
standard as part of an APM Entity group, but will receive their payment 
adjustment based only on the APM Entity score.
    Comment: In order to increase virtual group participation and 
incentivize solo practitioners and groups (including rural and small 
practices) to form virtual groups and move toward joint accountability, 
many commenters recommended that CMS provide bonus points to TINs that 
elect to form virtual groups given that virtual groups would face 
administrative and operational challenges, such as identifying reliable 
partners, aggregating and sharing data, and coordinating workflow 
across multiple TINs and NPIs. One commenter recommended that CMS 
consider granting virtual groups (of any size) special reporting and/or 
scoring accommodations similar to the previously finalized and proposed 
policies for small practices (for example, attesting to only one to two 
improvement activities) in order to account for the short timeframe (a 
few months) TINs have to form and implement virtual groups in 
preparation for the CY 2018 performance period.
    Response: We appreciate the recommendations from commenters. We 
believe that the ability for solo practitioners and groups to form and/
or join virtual groups is an advantage and provides flexibility. We 
note that virtual groups are generally able to take advantage and 
benefit from all scoring incentives and bonuses that are currently 
provided under MIPS. We will take into consideration the development of 
additional incentives, and any changes would be proposed in future 
rulemaking.
    Comment: One commenter requested that CMS consider scoring virtual 
groups by weighting each individual group category score by the number 
of clinicians. The commenter indicated that the requirement to 
consolidate scoring for each performance category would limit the 
ability of TINs to take advantage of the virtual group option, 
particularly with regard to the advancing care information performance 
category, where the use of different EHR vendors may make finding 
viable partners difficult and preclude easy reporting. Another 
commenter indicated that our proposal to require virtual groups to be 
scored across all performance categories may cause unintended 
consequences, such as virtual groups being dissuaded from admitting 
TINs that do have EHR technology certified to the 2014 Edition in order 
for virtual groups' advancing care information performance category 
scores not to be impacted.
    Response: We believe it is important for TINs participating in MIPS 
as part of a virtual group to be assessed and scored at the virtual 
group level across each performance category. We believe it provides 
continuity in assessment and allows virtual groups to share and 
coordinate resources pertaining to each performance category. We 
recognize that there may be challenges pertaining to aligning EHR 
technology and the ways in which EHR technology captures data, but 
believe that virtual groups have the opportunity to coordinate and 
identify means to align elements of EHR technology that would benefit 
the virtual group. In order for virtual groups to accurately have their 
performance assessed and scored as a collective entity and identify 
areas to improve care coordination, quality of care, and health 
outcomes, we believe that each eligible clinician in a virtual group 
should be assessed and scored across all four performance categories at 
the virtual group level.
    Comment: One commenter suggested that CMS explore the development 
of a test to determine, in advance, if a virtual group would have 
sufficient numbers for valid measurement.
    Response: We interpret the commenter's reference to ``sufficient 
numbers for valid measurement'' to mean sufficient numerator and 
denominator data to enable the data to accurately reflect the virtual 
group's performance on specific measures and activities. As virtual 
groups are implemented, we will take this recommendation into 
consideration.
    Comment: One commenter expressed concern that virtual groups would 
have the ability to skew benchmark scoring standards to the 
disadvantage of MIPS eligible clinicians who choose not to participate 
in MIPS as part of a virtual group.
    Response: We disagree with the commenter and do not believe that 
virtual groups would skew benchmark scoring standards to the 
disadvantage of MIPS eligible clinicians participating in MIPS at the 
individual or group level as a result of how benchmarks are calculated, 
which is based on the composite of available data for all MIPS eligible 
clinicians. MIPS eligible clinicians that are participating in MIPS as 
part of a virtual group would already be eligible and able to 
participate in MIPS at the individual or group level; therefore, the 
benchmark scoring standards would not be skewed regardless of such MIPS 
eligible clinicians participating in MIPS at the individual, group, or 
virtual group level. Also, we believe that solo practitioners and 
groups with 10 or fewer eligible clinicians that form virtual groups 
would increase their performance by joining together.
    Comment: One commenter urged CMS to address risk adjustment 
mechanisms for virtual groups and develop methodologies to account for 
the unique nature of virtual groups and noted that appropriate risk 
adjustment is critical for virtual groups because of the heterogeneous 
make-up of virtual groups (for example, geographic and specialty 
diversity).
    Response: We appreciate the recommendation from the commenter. 
Under the Improving Medicare Post-Acute Transformation (IMPACT) Act of 
2014, the Office of the Assistant Secretary for Planning and Evaluation 
(ASPE) has been conducting studies on the issue of risk adjustment for 
sociodemographic factors on quality measures and cost, as well as other 
strategies for including social

[[Page 53616]]

determinants of health status evaluation in CMS programs. We will 
closely examine the ASPE studies when they are available and 
incorporate findings as feasible and appropriate through future 
rulemaking. Also, we will monitor outcomes of beneficiaries with social 
risk factors, as well as the performance of the MIPS eligible 
clinicians who care for them to assess for potential unintended 
consequences such as penalties for factors outside the control of 
clinicians.
    Comment: One commenter requested clarification regarding how 
compliance would be implemented for the quality and improvement 
activities performance categories at the virtual group level and 
whether or not a virtual group would be able to achieve the highest 
possible score for the improvement activities performance category if 
only one NPI within the virtual group meets the requirements regardless 
of the total number of NPIs participating in the virtual group. Also, 
the commenter requested clarification regarding whether or not a 
virtual group would meet the requirements under the quality performance 
category if the virtual group included a TIN that reported a specialty 
measures set that is not applicable to other eligible clinicians in the 
virtual group.
    Response: As discussed in section II.C.4.d. of this final rule with 
comment period, we are generally applying our previously finalized and 
proposed group policies to virtual groups, unless specified. Thus, in 
order for virtual groups to meet the requirements for the quality and 
improvement activities performance categories, they would need to meet 
the same requirements established for groups and meet virtual group 
reporting requirements. Virtual groups will have their performance 
assessed and scored for the quality and improvement activities 
performance categories based submitting the minimum number of measures 
and activities. Generally, virtual groups reporting quality measures 
are required to select at least 6 measures, one of which must be an 
outcome measure, or if an outcome measure is not available a high 
priority measure to collectively report for the performance period of 
CY 2018. Virtual groups are encouraged to select the quality measures 
that are most appropriate to the TINs and NPIs within their virtual 
group and patient population.
    For the 2018 performance period, virtual groups submitting data on 
quality measures using QCDRs, qualified registries, or via EHR must 
report on at least 60 percent of the virtual group's patients that meet 
the measure's denominator criteria, regardless of payer for the 
performance period. We expect to receive quality data for both Medicare 
and non-Medicare patients under these submission mechanisms. Virtual 
groups submitting quality measures data using the CMS Web Interface or 
a CMS-approved survey vendor to report the CAHPS for MIPS survey must 
meet the data submission requirements on the sample of the Medicare 
Part B patients CMS provides. We note that the measure reporting 
requirements applicable to groups are also generally applicable to 
virtual groups. However, we note that the requirements for calculating 
measures and activities when reporting via QCDRs, qualified registries, 
EHRs, and attestation differ in their application to virtual groups. 
Specifically, these requirements apply cumulatively across all TINs in 
a virtual group. Thus, virtual groups will aggregate data for each NPI 
under each TIN within the virtual group by adding together the 
numerators and denominators and then cumulatively collate to report one 
measure ratio at the virtual group level. Moreover, if each MIPS 
eligible clinician within a virtual group faces a significant hardship 
or has EHR technology that has been decertified, the virtual group can 
apply for an exception to have its advancing care information 
performance category reweighted. If such exception application is 
approved, the virtual group's advancing care information performance 
category is reweighted to zero percent and applied to the quality 
performance category increasing the quality performance weight from 50 
percent to 75 percent.
    Additionally, the data submission criteria applicable to groups are 
also generally applicable to virtual groups. However, we note that data 
completeness and sampling requirements for the CMS Web Interface and 
CAHPS for MIPS survey differ in their application to virtual groups. 
Specifically, data completeness for virtual groups applies cumulatively 
across all TINs in a virtual group. Thus, we note that there may be a 
case when a virtual group has one TIN that falls below the 60 percent 
data completeness threshold, which is an acceptable case as long as the 
virtual group cumulatively exceeds such threshold. In regard to the CMS 
Web Interface and CAHPS for MIPS survey, sampling requirements pertain 
to Medicare Part B patients with respect to all TINs in a virtual 
group, where the sampling methodology would be conducted for each TIN 
within the virtual group and then cumulatively aggregated across the 
virtual group. A virtual group would need to meet the beneficiary 
sampling threshold cumulatively as a virtual group.
    In regard to performance under the improvement activities 
performance category, we clarified in the CY 2017 Quality Payment 
Program final rule (81 FR 77181) that if one MIPS eligible clinician 
(NPI) in a group completed an improvement activity, the entire group 
(TIN) would receive credit for that activity. In addition, we specified 
that all MIPS eligible clinicians reporting as a group would receive 
the same score for the improvement activities performance category if 
at least one clinician within the group is performing the activity for 
a continuous 90 days in the performance period. As discussed in section 
II.C.4.d. of this final rule with comment period, we are finalizing our 
proposal to generally apply our previously finalized and proposed group 
policies to virtual groups, unless otherwise specified. Thus, if one 
MIPS eligible clinician (NPI) in a virtual group completed an 
improvement activity, the entire virtual group would receive credit for 
that activity and receive the same score for the improvement activities 
performance category if at least one clinician within the virtual group 
is performing the activity for a minimum of a continuous 90-day period 
in CY 2018. In order for virtual groups to achieve full credit under 
the improvement activities performance category for the 2018 
performance period, they would need to submit four medium-weighted or 
two high-weighted activities that were for a minimum of a continuous 
90-day period in CY 2018. Virtual groups that are considered to be non-
patient facing or small practices, or designated as rural or HPSA 
practices will receive full credit by submitting one high-weighted 
improvement activity or two medium-weighted improvement activities that 
were conducted for a minimum of a continuous 90-day period in CY 2018.
    In regard to compliance with quality and improvement activities 
performance category requirements, virtual groups would meet the same 
performance category requirements applicable to groups. In section 
II.C.4.g. of this final rule with comment period, we outline virtual 
group reporting requirements. Virtual groups are required to adhere to 
the requirements established for each performance category. Performance 
data submitted to CMS on behalf of virtual groups must be meet form and 
manner requirements for each submission mechanism.

[[Page 53617]]

    Final Action: After consideration of the public comments received, 
we are finalizing the following proposals. Solo practitioners and 
groups with 10 or fewer eligible clinicians that have elected to be 
part of a virtual group will have their performance measured and 
aggregated at the virtual group level across all four performance 
categories. We will apply payment adjustments at the individual TIN/NPI 
level. Each TIN/NPI will receive a final score based on the virtual 
group performance, but the payment adjustment would still be applied at 
the TIN/NPI level. We will assign the virtual group score to all TIN/
NPIs billing under a TIN in the virtual group during the performance 
period.
    For participants in MIPS APMs, we will use our authority under 
section 1115A(d)(1) for MIPS APM authorized under section 1115A of the 
Act, and under section 1899(f) for the Shared Savings Program, to waive 
the requirement under section 1848 (q)(2)(5)(I)(i)(II) of the Act that 
requires performance category scores from virtual group reporting to be 
used to generate the final score upon which the MIPS payment adjustment 
is based for all TIN/NPIs in the virtual group. We will use the score 
assigned to the MIPS eligible clinician based on the applicable APM 
Entity score to determine MIPS payment adjustments for all MIPS 
eligible clinicians that are part of an APM Entity participating in a 
MIPS APM, in accordance with Sec.  414.1370, instead of determining 
MIPS payment adjustments for these MIPS eligible clinicians using the 
final score of their virtual group.
5. MIPS Performance Period
    In the CY 2017 Quality Payment Program final rule (81 FR 77085), we 
finalized at Sec.  414.1320(b)(1) that for purposes of the 2020 MIPS 
payment year, the performance period for the quality and cost 
performance categories is CY 2018 (January 1, 2018 through December 31, 
2018). We finalized at Sec.  414.1320(b)(2) that for purposes of the 
2020 MIPS payment year, the performance period for the improvement 
activities and advancing care information performance categories is a 
minimum of a continuous 90-day period within CY 2018, up to and 
including the full CY 2018 (January 1, 2018, through December 31, 
2018). We did not propose any changes to these policies.
    We also finalized at Sec.  414.1325(f)(2) that for Medicare Part B 
claims, data must be submitted on claims with dates of service during 
the performance period that must be processed no later than 60 days 
following the close of the performance period. In this final rule with 
comment period, we are finalizing three policies (small practice size 
determination, non-patient facing determination, and low-volume 
threshold determination) that utilize a 30-day claims run out. We refer 
readers to sections II.C.l.c., II.C.l.e., and II.C.2.c. of this final 
rule with comment period for details on these three policies. Lastly, 
we finalized that individual MIPS eligible clinicians or groups who 
report less than 12 months of data (due to family leave, etc.) are 
required to report all performance data available from the applicable 
performance period (for example, CY 2018 or a minimum of a continuous 
90-day period within CY 2018).
    We proposed at Sec.  414.1320(c)(1) that for purposes of the 2021 
MIPS payment year and future years, the performance period for the 
quality and cost performance categories would be the full calendar year 
(January 1 through December 31) that occurs 2 years prior to the 
applicable payment year. For example, for the 2021 MIPS payment year, 
the performance period would be CY 2019 (January 1, 2019 through 
December 31, 2019), and for the 2022 MIPS payment year, the performance 
period would be CY 2020 (January 1, 2020 through December 31, 2020).
    We proposed at Sec.  414.1320(d)(1) that for purposes of the 2021 
MIPS payment year, the performance period for the improvement 
activities and advancing care information performance categories would 
be a minimum of a continuous 90-day period within CY 2019, up to and 
including the full CY 2019 (January 1, 2019 through December 31, 2019).
    The following is a summary of the public comments received on the 
``MIPS Performance Period'' proposals and our responses:
    Comment: Many commenters did not support our proposal that 
beginning with the 2021 MIPS payment year, the performance period for 
the quality and cost performance categories would be the full calendar 
year that occurs 2 years prior to the applicable payment year. The 
commenters believed that MIPS eligible clinicians are not prepared to 
move from ``pick your pace'' flexibility to a full calendar year 
performance period and that the proposal would create significant 
administrative burden and confusion for MIPS eligible clinicians. A few 
commenters noted that a full calendar year of data does not necessarily 
improve the validity of the data. Many commenters recommended that CMS 
continue ``pick your pace'' flexibility with respect to the performance 
period, while several commenters expressed an interest in CMS allowing 
clinicians to choose the length of their performance period. One 
commenter recommended that CMS provide bonus points to clinicians who 
report for a performance period that is longer than 90 days. A few 
commenters recommended that CMS analyze the quality and cost 
performance data to determine the appropriate length of the performance 
period, taking into consideration whether there are any unintended 
consequences for practices of a particular size or specialty. One 
commenter suggested that CMS work with physicians to develop options 
and a specific plan to provide accommodations where possible, such as 
providing clinicians multiple different performance periods to choose 
from. A few commenters noted that a 90-day performance period may 
eliminate issues for clinicians that either switch or update their EHR 
system during the performance period. Furthermore, a few commenters 
noted that since the QCDR self-nominations are not due until November 
1, 2017, CMS would need to review and approve QCDR measures within less 
than 2 months, for clinicians to have QCDR measures to report at the 
start of the CY 2018 performance period. One commenter noted that a 90-
day performance period is preferable as clinicians will need time to 
update their systems and train staff after QCDR measures have been 
approved.
    Response: We understand the commenters' concerns. However, we 
believe that it would not be in the best interest of MIPS eligible 
clinicians to have less than a full calendar year performance period 
for the quality and cost performance categories beginning with the 2021 
MIPS payment year, as we previously finalized at Sec.  414.1320(b)(1) a 
full calendar year performance period for the quality and cost 
performance categories for the 2020 MIPS payment year, which will occur 
during CY 2018. By finalizing a full calendar year performance period 
for the quality and cost performance categories for the 2021 MIPS 
payment year, we are maintaining consistency with the performance 
period for the 2020 MIPS payment year. We believe this will be less 
burdensome and confusing for MIPS eligible clinicians. We also would 
like to note that a longer performance period for the quality and cost 
performance categories will likely include more patient encounters, 
which will increase the denominator of the quality and cost measures. 
Statistically, larger sample sizes provide more accurate and actionable 
information. Additionally, the longer performance

[[Page 53618]]

period (a year) is consistent with how many of the measures used in our 
program were designed to be reported and performed, such as Quality 
#303 (Cataracts: Improvement in Patient's Visual Function within 90 
Days Following Cataract Surgery) and Quality #304 (Cataracts: Patient 
Satisfaction within 90 Days Following Cataract Surgery). Finally, some 
of the measures do not allow for a 90-day performance period (such as 
those looking at complications after certain surgeries or improvement 
in certain conditions after treatment). In regards to the 
recommendation of providing bonus points to MIPS eligible clinicians 
that report for a performance period longer than 90 days, we believe a 
more appropriate incentive is for MIPS eligible clinicians to perform 
on a full year so that they have the ability to improve their 
performance due to having a larger sample size, etc. We also understand 
the commenters' preference of a 90-day performance period, so that 
there is adequate time to update systems and train staff. We agree that 
adequate time is needed to update systems, workflows and train staff. 
However, we note that the quality measures are finalized as part of 
this final rule, and the specifications are published on our Web site 
by no later than December 31 prior to the performance period. While we 
strongly encourage all clinicians to review the current performance 
period's measure specifications, we note that the overwhelming majority 
of MIPS quality measures are maintained year over year with only minor 
code set updates. Further, for quality, we have a 60 percent data 
completeness threshold, which provides a buffer for clinicians if they 
are not able to implement their selected measures immediately at the 
start of the performance period. Finally, we would like to clarify that 
many registries, QCDRs, and EHRs have the ability to accept historical 
data so that once the EHR system is switched or updated, the MIPS 
eligible clinician can report their information. With regard to the 
suggestion that we work with physicians to develop options and a 
specific plan to provide accommodations where possible, such as 
providing clinicians multiple different performance periods to choose 
from, we will consider this suggestion for future rulemaking as 
necessary.
    Comment: While we did not propose any changes to the previously 
finalized performance periods for the 2020 MIPS payment year, many 
commenters did not support a full calendar year performance period for 
the quality performance category for the 2020 MIPS payment year. The 
commenters noted that MIPS eligible clinicians are not prepared to move 
from ``pick your pace'' flexibility to a full calendar year performance 
period and that this policy will create significant administrative 
burden and confusion for MIPS eligible clinicians.
    Response: We understand the commenters' concerns in regards to the 
full calendar year MIPS performance period for the quality performance 
category for the 2020 MIPS payment year. We would like to note that the 
MIPS performance period for the 2020 MIPS payment year was finalized in 
the CY 2017 Quality Payment Program final rule, and we made no new 
proposals for the MIPS performance period for the 2020 MIPS payment 
year. Therefore, we are unable to modify the MIPS performance period 
for the quality performance category for the 2020 MIPS payment year.
    Comment: Several commenters supported the proposal to increase the 
performance period for the 2021 MIPS payment year and future payment 
years to 12 months occurring 2 years prior because the longer 
performance period provides a more accurate picture of eligible 
clinicians' performance. A few commenters noted that their support was 
contingent on CMS approving 2018 QCDR measure specifications by 
December 1, 2017. One commenter noted that a 90-day performance period 
is insufficient to thoroughly assess performance. One commenter noted 
that the full year will ensure continuity in the quality of care 
delivered to beneficiaries. One commenter noted that a TIN 
participating in Track 1 of the Shared Savings Program is automatically 
required to report for the full year, so requiring all MIPS eligible 
clinicians to participate for a full year would be fairer now that 
scores are reflected on Physician Compare.
    Response: We thank the commenters for their support. We would also 
like to note that in the CY 2017 Quality Payment Program final rule (81 
FR 77158), we stated that we would post the approved QCDR measures 
through the qualified posting by no later than January 1, 2018.
    Comment: A few commenters did not support the proposed performance 
periods because the quality and cost performance categories would not 
be aligned with the improvement activities and advancing care 
information performance categories. The commenters believed it would be 
confusing to clinicians. One commenter recommended that all performance 
categories have a 12-month performance period.
    Response: We understand the commenters' concerns that the proposed 
performance periods for quality and cost would not be consistent with 
the improvement activities and advancing care information performance 
categories. For the improvement activities performance category, a 
minimum of a continuous 90-day performance period provides MIPS 
eligible clinicians more flexibility as some improvement activities may 
be ongoing, while others may be episodic. For the advancing care 
information performance category, a minimum of a continuous 90-day 
period performance period provides MIPS eligible clinicians more 
flexibility and time to adopt and implement 2015 Edition CEHRT. As for 
the quality and cost performance categories, we believe that a full 
calendar year performance period is most appropriate. Additionally, 
submitting only 90 days of performance data may create challenges for 
specific measures. Finally, with respect to the cost performance 
category, we would like to note that no data submission is required, as 
this performance category is calculated utilizing Part B claim data.
    Comment: Many commenters supported the proposed 90-day performance 
period for the improvement activities and advancing care information 
performance categories. A few commenters requested that CMS adopt a 90-
day performance period for the improvement activities and advancing 
care information performance categories for the 2022 MIPS payment year 
and future years.
    Response: We thank the commenters for their support and will 
consider the commenters' recommendation for future rulemaking.
    Comment: A few commenters did not support the length of time 
between the proposed performance period and the applicable payment year 
because the commenters believed it would not allow practices time to 
make necessary adjustments before the next performance period begins. 
One commenter recommended that, as the program matures, one 
consideration for shortening this timeframe could be a quarterly 
rolling annual performance period with a three- to 6-month validation 
period prior to any payment adjustment. Another commenter recommended 
that we consider staggered performance periods; for example payment 
adjustments for 2021, would ideally be based on a performance period 
running from July 1, 2019 through June 30, 2020.
    Response: We understand the commenters' concerns regarding the 
length of time between the proposed

[[Page 53619]]

performance period and the applicable payment year and appreciate the 
commenters' suggestions for shortening this timeframe. While a 
shortened timeframe between performance period and payment year may be 
desirable, there are operational challenges with this approach that we 
do not anticipate can be resolved in the near future. Specifically, we 
need to allow time for the post submission processes of calculating 
MIPS eligible clinicians' final scores, establishing budget neutrality, 
issuing the payment adjustment factors, and allowing for a targeted 
review period to occur prior to the application of the MIPS payment 
adjustment to MIPS eligible clinicians' claims. However, we are 
continuing to look for opportunities to shorten the timeframe between 
the end of the performance period and when payment adjustments are 
applied.
    Comment: One commenter recommended a 2-year performance period for 
clinicians who have patient volume insufficient for statistical 
analysis so that the clinician has a sufficient sample size to analyze.
    Response: We thank the commenter for their suggestion and will 
consider it for future rulemaking. We would like to note that in this 
final rule with comment period, we are only finalizing the performance 
period for the 2021 MIPS payment year, not future years, so that we can 
continue to monitor and assess whether changes to the performance 
period through future rulemaking would be beneficial.
    Comment: One commenter encouraged CMS to implement the MIPS program 
as soon as possible. This commenter noted that a transition period 
could discourage eligible clinicians from participating in the program.
    Response: We appreciate the commenter's recommendation to implement 
the MIPS program as soon as possible; however, we disagree that a 
transition period will discourage participation. We believe that a 
transition period will reduce barriers from participation that existed 
in the legacy programs.
    Final Action: After consideration of the public comments, we are 
finalizing at Sec.  414.1320(c)(1) that for purposes of the 2021 MIPS 
payment year, the performance period for the quality and cost 
performance categories is CY 2019 (January 1, 2019 through December 31, 
2019). We are not finalizing the proposed performance period for the 
quality and cost performance categories for purposes of the 2022 MIPS 
payment year and future years. We are also redesignating proposed Sec.  
414.1320(d)(1) and finalizing at Sec.  414.1320(c)(2) that for purposes 
of the 2021 MIPS payment year, the performance period for the advancing 
care information and improvement activities performance categories is a 
minimum of a continuous 90-day period within CY 2019, up to and 
including the full CY 2019 (January 1, 2019 through December 31, 2019).
6. MIPS Performance Category Measures and Activities
a. Performance Category Measures and Reporting
(1) Submission Mechanisms
    We finalized in the CY 2017 Quality Payment Program final rule (81 
FR 77094) at Sec.  414.1325(a) that individual MIPS eligible clinicians 
and groups must submit measures and activities, as applicable, for the 
quality, improvement activities, and advancing care information 
performance categories. For the cost performance category, we finalized 
that each individual MIPS eligible clinician's and group's cost 
performance would be calculated using administrative claims data. As a 
result, individual MIPS eligible clinicians and groups are not required 
to submit any additional information for the cost performance category. 
We finalized in the CY 2017 Quality Payment Program final rule (81 FR 
77094 through 77095) multiple data submission mechanisms for MIPS, 
which provide individual MIPS eligible clinicians and groups with the 
flexibility to submit their MIPS measures and activities in a manner 
that best accommodates the characteristics of their practice, as 
indicated in Tables 2 and 3. Table 2 summarizes the data submission 
mechanisms for individual MIPS eligible clinicians that we finalized at 
Sec.  414.1325(b) and (e). Table 3 summarizes the data submission 
mechanisms for groups that are not reporting through an APM that we 
finalized at Sec.  414.1325(c) and (e).

    Table 2--Data Submission Mechanisms for MIPS Eligible Clinicians
                         Reporting Individually
                                [TIN/NPI]
------------------------------------------------------------------------
  Performance category/submission   Individual reporting data submission
       combinations accepted                     mechanisms
------------------------------------------------------------------------
Quality...........................  Claims.
                                    QCDR.
                                    Qualified registry.
                                    EHR.
Cost..............................  Administrative claims.\1\
Advancing Care Information........  Attestation.
                                    QCDR.
                                    Qualified registry.
                                    EHR.
Improvement Activities............  Attestation.
                                    QCDR.
                                    Qualified registry.
                                    EHR.
------------------------------------------------------------------------


    Table 3--Data Submission Mechanisms for MIPS Eligible Clinicians
                           Reporting as Groups
                                  [TIN]
------------------------------------------------------------------------
  Performance category/submission      Group reporting data submission
       combinations accepted                     mechanisms
------------------------------------------------------------------------
Quality...........................  QCDR.
                                    Qualified registry.
                                    EHR.

[[Page 53620]]

 
                                    CMS Web Interface (groups of 25 or
                                     more).
                                    CMS-approved survey vendor for CAHPS
                                     for MIPS (must be reported in
                                     conjunction with another data
                                     submission mechanism).
                                    and
                                    Administrative claims (for all-cause
                                     hospital readmission measure; no
                                     submission required).
Cost..............................  Administrative claims.\1\
Advancing Care Information........  Attestation.
                                    QCDR.
                                    Qualified registry.
                                    EHR.
                                    CMS Web Interface (groups of 25 or
                                     more).
Improvement Activities............  Attestation.
                                    QCDR.
                                    Qualified registry.
                                    EHR.
                                    CMS Web Interface (groups of 25 or
                                     more).
------------------------------------------------------------------------

    We finalized at Sec.  414.1325(d) that individual MIPS eligible 
clinicians and groups may elect to submit information via multiple 
mechanisms; however, they must use the same identifier for all 
performance categories, and they may only use one submission mechanism 
per performance category.
---------------------------------------------------------------------------

    \1\ Requires no separate data submission to CMS: Measures are 
calculated based on data available from MIPS eligible clinicians' 
billings on Medicare Part B claims. Note: Claims differ from 
administrative claims as they require MIPS eligible clinicians to 
append certain billing codes to denominator eligible claims to 
indicate the required quality action or exclusion occurred.
---------------------------------------------------------------------------

    We proposed to revise Sec.  414.1325(d) for purposes of the 2020 
MIPS payment year and future years, beginning with performance periods 
occurring in 2018, to allow individual MIPS eligible clinicians and 
groups to submit data on measures and activities, as applicable and 
available, via multiple data submission mechanisms for a single 
performance category (specifically, the quality, improvement 
activities, or advancing care information performance category) (82 FR 
30035). Under this proposal, individual MIPS eligible clinicians and 
groups that have fewer than the required number of measures and 
activities applicable and available under one submission mechanism 
could submit data on additional measures and activities via one or more 
additional submission mechanisms, as necessary, to receive a potential 
maximum number of points under a performance category.
    If an individual MIPS eligible clinician or group submits the same 
measure through two different mechanisms, each submission would be 
calculated and scored separately. We do not have the ability to 
aggregate data on the same measure across submission mechanisms. We 
would only count the submission that gives the clinician the higher 
score, thereby avoiding the double count. We refer readers to section 
II.C.7.a.(2) of this final rule with comment period, which further 
outlines how we proposed to score measures and activities regardless of 
submission mechanism.
    We believe that this flexible approach would help individual MIPS 
eligible clinicians and groups with reporting, as it provides more 
options for the submission of data for the applicable performance 
categories. We believe that by providing this flexibility, we would be 
allowing MIPS eligible clinicians to choose the measures and activities 
that are most meaningful to them, regardless of the submission 
mechanism. We are aware that this proposal for increased flexibility in 
data submission mechanisms may increase complexity and in some 
instances necessitate additional costs for clinicians, as they may need 
to establish relationships with additional data submission mechanism 
vendors in order to report additional measures and/or activities for 
any given performance category. We clarified that the requirements for 
the performance categories remain the same, regardless of the number of 
submission mechanisms used. It is also important to note that for the 
improvement activities and advancing care information performance 
categories, that using multiple data submission mechanisms may limit 
our ability to provide real-time feedback. While we strive to provide 
flexibility to individual MIPS eligible clinicians and groups, we noted 
that our goal within the MIPS program is to minimize complexity and 
administrative burden to individual MIPS eligible clinicians and 
groups.
    As discussed in section II.C.4 of this final rule with comment 
period, we proposed to generally apply our previously finalized and 
proposed group policies to virtual groups. With respect to data 
submission mechanisms, we proposed that virtual groups would be able to 
use a different submission mechanism for each performance category, and 
would be able to utilize multiple submission mechanisms for the quality 
performance category, beginning with performance periods occurring in 
2018 (82 FR 30036). However, virtual groups would be required to 
utilize the same submission mechanism for the improvement activities 
and the advancing care information performance categories.
    For those MIPS eligible clinicians participating in a MIPS APM, who 
are on an APM Participant List on at least one of the three snapshot 
dates as finalized in the CY 2017 Quality Payment Program Final Rule 
(81 FR 77444 through 77445), or for MIPS eligible clinicians 
participating in a full TIN MIPS APM, who are on an APM Participant 
List on at least one of the four snapshot dates as discussed in section 
II.C.6.g.(2) of this final rule with comment period, the APM scoring 
standard applies. We refer readers to Sec.  414.1370 and the CY 2017 
Quality Payment Program final rule (81 FR 77246), which describes how 
MIPS eligible clinicians participating in APM entities submit data to 
MIPS in the form and manner required, including separate approaches to 
the quality and cost performance categories applicable to MIPS APMs. We 
did not propose any changes to how APM entities in MIPS APMs and their 
participating MIPS eligible clinicians submit data to MIPS.

[[Page 53621]]

    The following is a summary of the public comments received on the 
``Performance Category Measures and Reporting: Submission Mechanisms'' 
proposal and our responses:
    Comment: Many commenters supported the proposal to allow MIPS 
eligible clinicians and groups to submit measures and activities via 
multiple submission mechanisms. Several commenters noted it will help 
ease reporting and administrative burden. Several commenters also noted 
it will provide greater flexibility, including increasing the number of 
measures available. Several commenters stated it will allow clinicians 
to report the measures that are most meaningful and applicable to them. 
Several commenters also stated it will help MIPS eligible clinicians 
and groups successfully report required measures and meet MIPS 
reporting requirements. A few commenters specifically supported the 
policy to allow reporting of quality measures across multiple data 
submission mechanisms because 6 clinically-applicable quality measures 
may not always be available using one submission mechanism; it will 
provide clinicians who belong to multi-specialty groups more ease in 
reporting quality measures they may be already reporting to qualified 
vendors, versus forcing different specialties to find a common 
reporting platform that causes much more administrative, and often 
financial burden; it will allow greater flexibility in measure 
selection and will particularly benefit specialists who may want to 
report one or 2 eCQMs but will need to use a registry to report the 
rest of their measure set; and it is especially helpful for those who 
want to report via EHR to the extent possible even though not all 
measures can be submitted via that mechanism. One commenter asked if 
specialists who would have used a specialty measure set would be 
required to use multiple submission methods to meet the 6-measure 
requirement.
    Response: We appreciate the commenters support for our proposal. 
Due to operational feasibility concerns, we are not finalizing this 
proposal beginning with the CY 2018 performance period as proposed, but 
instead beginning with the CY 2019 performance period. Moreover, we are 
not requiring that MIPS individual clinicians and groups submit via 
additional submission mechanisms; however, through this proposal the 
option would be available for those that have applicable measures and/
or activities available to them. As discussed in section 
II.C.7.a.(2)(e) of this final rule with comment period, beginning with 
the CY 2019 performance period, we will apply our validation process to 
determine if other measures are available and applicable only with 
respect to the data submission mechanism(s) that a MIPS eligible 
clinician utilizes for the quality performance category for a 
performance period. With regard to a specialty measure set, specialists 
who report on a speciality measure set are only required to report on 
the measures within that set, even if it is less than the required 6 
measures. If the specialty set includes measures that are available 
through multiple submission mechanisms, then through this policy, 
beginning with the 2019 performance period, the option to report 
additional measures would be available for those that have applicable 
measures and/or activities available to them, which may potentially 
increase their score, but they are not required to utilize multiple 
submission methods to meet the 6 measure requirement. In addition, for 
MIPS eligible clinicians reporting on a specialty measure set via 
claims or registry, we will apply our validation process to determine 
if other measures are available and applicable within the specialty 
measure set only with respect to the data submission mechanism(s) that 
a MIPS eligible clinician utilizes for the quality performance category 
for a performance period.
    Comment: A few commenters stated this proposal will allow MIPS 
eligible clinicians to determine which method is most appropriate for 
the different MIPS categories. Several commenters noted it will 
encourage MIPS participation. Many commenters stated it will encourage 
the reporting of measures through new submission methods such as QCDRs 
and EHRs. A few commenters stated it will reduce burden on clinicians 
and EHR vendors by allowing large groups that report under different 
EHRs to report using multiple EHRs.
    Response: In the CY 2017 Quality Payment Program final rule, we 
finalized that for the quality performance category, an individual MIPS 
eligible clinician or group that submits data on quality measures via 
EHR, QCDR, qualified registry, claims, or a CMS-approved survey vendor 
for the CAHPS for MIPS survey will be assigned measure achievement 
points for 6 measures (1 outcome, or if an outcome measure is not 
available, another high priority measure and the next 5 highest scoring 
measures) as available and applicable, and we will receive applicable 
measure bonus points for all measures submitted that meet the bonus 
criteria (81 FR 77282 through 77301). Consistent with this policy, we 
would like to clarify that for performance periods beginning in 2019, 
if a MIPS eligible clinician or group reports for the quality 
performance category by using multiple instances of the same data 
submission mechanism (for example, multiple EHRs) then all the 
submissions would be scored, and the 6 quality measures with the 
highest performance (that is, the greatest number of measure 
achievement points) would be utilized for the quality performance 
category score. As noted above, if an individual MIPS eligible 
clinician or group submits the same measure through two different 
mechanisms, each submission would be calculated and scored separately. 
We do not have the ability to aggregate data on the same measure across 
multiple submission mechanisms. We would only count the submission that 
gives the clinician the higher score, thereby avoiding the double 
count. For example, if a MIPS eligible clinician submits performance 
data for Quality Measure 236, Controlling High Blood Pressure, using a 
registry and also through an EHR, these two submissions would be scored 
separately, and we would apply the submission with the higher score 
towards the quality performance score. We would not aggregate the score 
of the registry and EHR submission of the same measure. This approach 
decreases the likelihood of cumulative overcounting in the event that 
the submissions may have time or patient overlaps that may not be 
readily identifiable.
    Comment: One commenter supported that virtual groups would be able 
to use multiple submission mechanisms for quality reporting but would 
have to use the same submission mechanism for the improvement 
activities and advancing care information performance categories. A few 
commenters suggested that both groups and virtual groups have the same 
submission requirements. Another commenter suggested that we reconsider 
multiple submission mechanisms due to the complexity it will place on 
clinicians.
    Response: We are not finalizing our proposal that virtual groups 
would be required to utilize the same submission mechanism for the 
improvement activities and the advancing care information performance 
categories because we believe that virtual groups should have the same 
reporting capabilities as groups. Thus, groups and virtual groups have 
the same submission requirements, which for the CY 2018 performance 
period, includes the utilization of multiple submission mechanisms with 
the caveat that only one submission mechanism must be used per 
performance category. Starting

[[Page 53622]]

with the CY 2019 performance period, groups and virtual groups will be 
able to utilize multiple submission mechanisms for each performance 
category. As noted above, due to operational feasibility concerns, we 
are not finalizing this proposal beginning with the CY 2018 performance 
period as proposed, but instead beginning with the CY 2019 performance 
period.
    Comment: A few commenters stated this proposal would help 
clinicians and groups receive the maximum number of points available. 
One commenter noted it will ease the path for small and rural practice 
clinicians to participate in MIPS. One commenter stated it will support 
reporting the highest quality data available. One commenter noted it 
may allow clinicians to complete more activities. One commenter noted 
it will provide EHR and registry vendors flexibility in submitting data 
on behalf of their customers. One commenter stated that while it may 
add some burdens to reporting quality measures because MIPS eligible 
clinicians will be required to report on 6 quality measures instead of 
only the number available via a given submission mechanism, they stated 
that they believe it will ultimately drive adoption of more robust 
measures based on clinical data and outcomes.
    Response: We note that under this policy, individual MIPS eligible 
clinicians and groups are not required to, but may use multiple data 
submission mechanisms to report on six quality measures in order to 
potentially achieve the maximum score for the quality performance 
category beginning with the 2019 performance period. Individual MIPS 
eligible clinicians and groups could report on additional measures and/
or activities using multiple data submission mechanisms for the 
Quality, Advancing Care Information, and Improvement Activities 
performance categories should applicable measures and/or activities be 
available to them. We agree that this policy provides small and rural 
practice clinicians with additional flexibility to participate in MIPS 
by not limiting them to the use of one submission mechanism per 
performance category. We believe that MIPS eligible clinicians and 
groups should select and report on measures that provide meaningful 
measurement within the scope of their practice that should include a 
focus on more outcomes-based measurement.
    Comment: One commenter who supported the proposal expressed concern 
that the flexibility may create more complexity and confusion, as well 
as burden on CMS. Another commenter stated that while there could be 
some burdens with requiring clinicians to use multiple submission 
mechanisms, if they have fewer than the required number of measures and 
activities applicable and available under one submission mechanism, as 
the requirements for the performance categories remain the same 
regardless of the number of submission mechanisms used. A commenter 
expressed concern with making multiple submissions part of the measure 
validation process for the review of whether 6 measures are available 
for reporting.
    Response: We appreciate the commenters support for our proposal. 
Due to operational feasibility concerns, we are not finalizing this 
proposal beginning with the CY 2018 performance period as proposed, but 
instead beginning with the CY 2019 performance period. Moreover, we are 
not requiring that MIPS individual clinicians and groups submit via 
additional submission mechanisms; however, through this proposal the 
option would be available for those that have applicable measures and/
or activities available to them. As discussed in section 
II.C.7.a.(2)(e) of this final rule with comment period, beginning with 
the CY 2019 performance period, we will apply our validation process to 
determine if other measures are available and applicable only with 
respect to the data submission mechanism(s) that a MIPS eligible 
clinician utilizes for the quality performance category for a 
performance period. With regard to a specialty measure set, specialists 
who report on a speciality measure set are only required to report on 
the measures within that set, even if it is less than the required 6 
measures. If the specialty set includes measures that are available 
through multiple submission mechanisms, then through this policy, 
beginning with the 2019 performance period, the option to report 
additional measures would be available for those that have applicable 
measures and/or activities available to them, which may potentially 
increase their score, but they are not required to utilize multiple 
submission methods to meet the 6 measure requirement. In addition, for 
MIPS eligible clinicians reporting on a specialty measure set via 
claims or registry, we will apply our validation process to determine 
if other measures are available and applicable within the specialty 
measure set only with respect to the data submission mechanism(s) that 
a MIPS eligible clinician utilizes for the quality performance category 
for a performance period.
    Comment: A few commenters offered additional recommendations 
including: That CMS eventually require a MIPS eligible clinician or 
group to submit all data on measures and activities across a single 
data submission mechanism of their choosing to ensure that reliable, 
trustworthy, comparative data can be extracted from the MIPS eligible 
clinician and/or group's MIPS performance information and to alleviate 
the resource intensity associated with retaining all data across the 
multiple submission mechanisms for auditing purposes; and that claims-
only reporting for the quality performance category be phased-out due 
to difficulty with clinically abstracting meaningful quality data.
    Response: We thank the commenter for their recommendations 
regarding using a single data submission mechanism and phasing out 
claims-only reporting for the quality performance category, and will 
take their recommendations into consideration for future rulemaking. We 
refer readers to section II.C.9.c of this final rule with comment 
period for a discussion of our data validation and auditing policies.
    Comment: Commenters requested that CMS continue to look for ways to 
increase flexibility in the Quality Payment Program and believed the 
best way to ensure participating clinicians can meet the requirements 
of each performance category is to increase the number of meaningful 
measures available. For clinicians who do not want to manage multiple 
submission mechanisms an alternative solution would be for each 
specialty within a group to create their own TINs and report as 
subgroups, because the commenter stated that allowing all MIPS eligible 
groups to report unique sets of measures via a single mechanism or 
multiple mechanisms promotes the ability for all clinicians to have a 
meaningful impact on overall MIPS performance, although the commenter 
recognized that this subgroup approach could create challenges with the 
current MIPS group scoring methodology.
    Response: We agree that reporting on quality measures should be 
meaningful for clinicians, and note that measures are taken into 
consideration on an annual basis prior to rule-making and we encourage 
stakeholders to communicate their concerns regarding gaps in measure 
development to measure stewards. We thank commenters for their 
suggestions regarding an alternative approach to submission mechanisms. 
We would like to clarify that each newly created TIN would be 
considered a new group, and as discussed in the CY 2018 Quality Payment 
Program proposed rule (82 FR 30027), we intend to explore the

[[Page 53623]]

feasibility of establishing group-related policies that would permit 
participation in MIPS at a subgroup level through future rulemaking. We 
refer readers section II.C.3. of this final rule with comment period 
for additional information regarding group reporting.
    Comment: Commenters suggested that CMS ensure that entire specialty 
specific measure sets can be reported through a single submission 
mechanism of their choice, specifically expressing concern for the 
measures within the radiation oncology subspecialty measure set.
    Response: We would like to note that a majority of the measures in 
the specialty measure sets are available through registry reporting, 
and that specifically to the commenters concern, that all the measures 
within the radiation oncology subspecialty measure set are available 
through registry reporting. A majority of the quality measures in the 
MIPS program are not owned by CMS, but rather are developed and 
maintained by third party measure stewards. As a part of measure 
development and maintenance, measure stewards conduct feasibility 
testing of adding a new submission mechanism as a reporting option for 
their measure. We will share this recommendation with the measure 
stewards for future consideration.
    Comment: One commenter suggested that CMS retroactively provide 
similar flexibility for the CY 2017 MIPS performance period.
    Response: For operational and feasibility reasons, we believe that 
it would not be possible to retroactively allow MIPS individual 
eligible clinicians and groups to submit data through multiple 
submission mechanisms for the CY 2017 MIPS performance period.
    Comment: Some commenters suggested that CMS not overly rely on 
claims-based measures to drive quality improvement and scoring in 
future program years, that CMS develop a transition plan toward only 
accepting data from electronic systems that have demonstrated abilities 
to produce valid measurement, such as those EHRs that have achieved 
NCQA eMeasure Certification; and that CMS create educational programs 
to help clinicians and groups understand the multiple submission 
option. A few commenters recommended making more quality measures 
available under each of the submission mechanisms so MIPS eligible 
clinicians have sufficient measures within a single submission 
mechanism. One commenter stated it would inadvertently advantage large 
practices that may be better equipped to track measures. One commenter 
asked for clarification to distinguish between the scenarios where a 
clinician is required to submit under both EHR and registry because 
their EHR is not certified for enough measures and when a clinician is 
required to submit under both EHR and registry because CMS has not 
created enough electronic measures for the clinician's specialty.
    Response: We appreciate the suggestions, and will take them into 
consideration for future rulemaking. As indicated in the CY 2017 
Quality Payment Program final rule (81 FR 77090), we intend to reduce 
the number of claims-based measures in the future as more measures are 
available through health IT mechanisms that produce valid measurement 
such as registries, QCDRs, and health IT vendors. We plan to 
continuously work with MIPS eligible clinicians and other stakeholders 
to continue to improve the submission mechanisms available for MIPS. We 
agree that there is value to EHR based reporting; however, we recognize 
that there are relatively fewer measures available via EHR reporting 
and we generally want to retain solutions that are low burden unless 
and until we identify viable alternatives. As indicated in the quality 
measures appendices in this final rule with comment period, we are 
finalizing 54 out of the 275 quality measures available through EHR 
reporting for the CY 2018 performance period. MIPS eligible clinicians 
should evaluate the options available to them and choose which 
available submission mechanism and measures they believe will provide 
meaningful measurement for their scope of practice. We intend to 
provide stakeholders with additional education with regards to the use 
of multiple submission mechanisms by the implementation of this policy 
for the CY 2019 performance period. We plan to continuously work with 
MIPS eligible clinicians and other stakeholders to continue to improve 
the submission mechanisms available for MIPS. It is not our intent to 
provide larger practices an advantage over smaller practices, rather 
our intention is to provide all MIPS eligible clinicians and groups the 
opportunity to submit data on measures that are available and 
applicable to their scope of practice. We are not requiring that MIPS 
individual clinicians and groups submit via additional submission 
mechanisms; however, through this proposal the option would be 
available for those that have applicable measures and/or activities 
available to them. As discussed in section II.C.7.a.(2)(e) of this 
final rule with comment period, beginning with the CY 2019 performance 
period, we will apply our validation process to determine if other 
measures are available and applicable only with respect to the data 
submission mechanism(s) that a MIPS eligible clinician utilizes for the 
quality performance category for a performance period. With regard to a 
specialty measure set, specialists who report on a speciality measure 
set are only required to report on the measures within that set, even 
if it is less than the required 6 measures. If the specialty set 
includes measures that are available through multiple submission 
mechanisms, then through this policy, beginning with the 2019 
performance period, the option to report additional measures would be 
available for those that have applicable measures and/or activities 
available to them, which may potentially increase their score, but they 
are not required to utilize multiple submission methods to meet the 6 
measure requirement. In addition, for MIPS eligible clinicians 
reporting on a specialty measure set via claims or registry, we will 
apply our validation process to determine if other measures are 
available and applicable within the specialty measure set only with 
respect to the data submission mechanism(s) that a MIPS eligible 
clinician utilizes for the quality performance category for a 
performance period.
    Comment: Several commenters recommended that CMS make multiple 
submission mechanisms optional only. A few commenters expressed concern 
that a requirement to report via multiple mechanisms to meet the 
required 6 measures in the quality performance category would increase 
burden on MIPS eligible clinicians and groups that are unable to meet 
the minimum requirement using one submission mechanism. A few 
commenters stated that MIPS eligible clinicians and groups should not 
be required to contract with vendors and pay to report data on 
additional quality measures that are not reportable through their 
preferred method or be penalized for failing to report additional 
measures via a second submission mechanism and that CMS should only 
review the measures available to a clinician or group given their 
chosen submission mechanism--claims, registry, EHR or QCDR--to 
determine if they could have reported on additional measures. A few 
commenters recommended that CMS only offer multiple submission 
mechanisms as an option that could earn a clinician bonus points to 
recognize investment in an additional submission mechanism. One 
commenter

[[Page 53624]]

recommended that reporting using more than one submission mechanism be 
required for a given performance period only if the MIPS eligible 
clinician or group already has an additional submission mechanism in 
place that could be utilized to submit additional measures.
    Response: We are not requiring that MIPS individual clinicians and 
groups submit via additional submission mechanisms; however, through 
this proposal the option would be available for those that have 
applicable measures and/or activities available to them. As discussed 
in section II.C.7.a.(2)(e) of this final rule with comment period, 
beginning with the CY 2019 performance period, we will apply our 
validation process to determine if other measures are available and 
applicable only with respect to the data submission mechanism(s) that a 
MIPS eligible clinician utilizes for the quality performance category 
for a performance period. With regard to a specialty measure set, 
specialists who report on a speciality measure set are only required to 
report on the measures within that set, even if it is less than the 
required 6 measures. If the specialty set includes measures that are 
available through multiple submission mechanisms, then through this 
policy, beginning with the 2019 performance period, the option to 
report additional measures would be available for those that have 
applicable measures and/or activities available to them, which may 
potentially increase their score, but they are not required to utilize 
multiple submission methods to meet the 6 measure requirement. In 
addition, for MIPS eligible clinicians reporting on a specialty measure 
set via claims or registry, we will apply our validation process to 
determine if other measures are available and applicable within the 
specialty measure set only with respect to the data submission 
mechanism(s) that a MIPS eligible clinician utilizes for the quality 
performance category for a performance period.
    Comment: Many commenters did not support our proposal to allow 
submission of measures via multiple submission mechanisms or expressed 
concerns with the proposal. Several commenters expressed concern that 
it would add burden, confusion, and complexity for MIPS eligible 
clinicians and groups, as well as vendors, possibly requiring them to 
track measures across mechanisms based on varying benchmarks and to 
review measures and tools to determine if there are additional 
applicable measures.
    Response: We understand the commenters concerns with regards to 
burden and complexity around the use of multiple submission mechanisms. 
we are not requiring that MIPS individual clinicians and groups submit 
via additional submission mechanisms; however, through this proposal 
the option would be available for those that have applicable measures 
and/or activities available to them. As discussed in section 
II.C.7.a.(2)(e) of this final rule with comment period, beginning with 
the CY 2019 performance period, we will apply our validation process to 
determine if other measures are available and applicable only with 
respect to the data submission mechanism(s) that a MIPS eligible 
clinician utilizes for the quality performance category for a 
performance period. With regard to a specialty measure set, specialists 
who report on a speciality measure set are only required to report on 
the measures within that set, even if it is less than the required 6 
measures. If the specialty set includes measures that are available 
through multiple submission mechanisms, then through this policy, 
beginning with the 2019 performance period, the option to report 
additional measures would be available for those that have applicable 
measures and/or activities available to them, which may potentially 
increase their score, but they are not required to utilize multiple 
submission methods to meet the 6 measure requirement. In addition, for 
MIPS eligible clinicians reporting on a specialty measure set via 
claims or registry, we will apply our validation process to determine 
if other measures are available and applicable within the specialty 
measure set only with respect to the data submission mechanism(s) that 
a MIPS eligible clinician utilizes for the quality performance category 
for a performance period.
    Comment: A few commenters expressed concern that this policy could 
substantially increase costs and burden for MIPS eligible clinicians, 
as it may require a MIPS eligible clinician or group practice to 
purchase an additional data submission mechanism in order to report 6 
measures, and another commenter expressed concern for financial impact 
on small and solo practices. A few commenters stated that it would 
increase costs to vendors, which would be passed on to customers and 
patients. One commenter expressed concern regarding decreased 
productivity, and increased opportunity for coding errors. A few 
commenters expressed concern that they may be required to report on 
measures that are potentially not clinically relevant. One commenter 
noted that requiring the clinician to use multiple submission 
mechanisms would penalize them for something out of their control, 
specifically development of specialty-specific eCQMs, noting that even 
with software certified to all 64 eCQMs, fewer than 6 have a positive 
denominator. A few commenters expressed concern with how this proposal 
would interact with the measure validation process to determine whether 
a clinician could have reported additional measures, specifically 
expressing concern that it would require eligible clinicians to look 
across multiple mechanisms to fulfill the 6-measure requirement and 
that MIPS eligible clinicians should not be held accountable to meet 
more measures or look across submission mechanisms, and potentially 
invest in multiple mechanisms, because CMS is making additional 
submission mechanisms available.
    Response: We are not requiring that MIPS individual clinicians and 
groups submit via additional submission mechanisms; however, through 
this proposal the option would be available for those that have 
applicable measures and/or activities available to them. As discussed 
in section II.C.7.a.(2)(e) of this final rule with comment period, 
beginning with the CY 2019 performance period, we will apply our 
validation process to determine if other measures are available and 
applicable only with respect to the data submission mechanism(s) that a 
MIPS eligible clinician utilizes for the quality performance category 
for a performance period. With regard to a specialty measure set, 
specialists who report on a speciality measure set are only required to 
report on the measures within that set, even if it is less than the 
required 6 measures. If the specialty set includes measures that are 
available through multiple submission mechanisms, then through this 
policy, beginning with the 2019 performance period, the option to 
report additional measures would be available for those that have 
applicable measures and/or activities available to them, which may 
potentially increase their score, but they are not required to utilize 
multiple submission methods to meet the 6 measure requirement. In 
addition, for MIPS eligible clinicians reporting on a specialty measure 
set via claims or registry, we will apply our validation process to 
determine if other measures are available and applicable within the 
specialty measure set only with respect to the data submission 
mechanism(s) that a MIPS eligible clinician utilizes for the quality

[[Page 53625]]

performance category for a performance period.
    Comment: One commenter recommended that CMS withhold the option for 
submission through multiple mechanisms in the quality category for 
future implementation, or until CMS has become comfortable with the 
data received in year 1 of the program.
    Response: We agree with the commenter and due to operational 
feasibility concerns, we have determined that this proposal will be 
implemented beginning with the CY 2019 performance period. By the time 
this proposal is implemented for the CY 2019 performance period, we 
will have greater familiarity with which the way data is submitted to 
CMS based off submissions from the CY 2017 performance period.
    Comment: One commenter asked that CMS confirm that a MIPS eligible 
clinician would be allowed to submit data using multiple QCDRs under 
the same TIN/NPI or TIN because allowing submission via multiple QCDRs 
in single TIN could serve as a pathway forward for greater specialist 
participation within multispecialty groups.
    Response: A MIPS individual eligible clinician or group would be 
able to submit data using multiple QCDRs if they are able to find 
measures supported by other QCDRs that would provide meaningful 
measurement for the clinicians, and those measures are applicable. 
Consistent with the policy finalized in the CY 2017 Quality Payment 
Program final rule (81 FR 77282 through 77301), we would like to 
clarify that beginning with the CY 2019 performance period, if a MIPS 
eligible clinician or group reports for the quality performance 
category by using multiple instances of the same submission mechanism 
(for example, multiple QCDRs), then all the submissions would be 
scored, and the 6 quality measures with the highest performance (that 
is, the greatest number of measure achievement points) would be 
utilized for the quality performance category score. As noted above, if 
an individual MIPS eligible clinician or group submits the same measure 
through two different submission mechanisms, each submission would be 
calculated and scored separately. We do not have the ability to 
aggregate data on the same measure across submission mechanisms. 
Similarly, data completeness cannot be combined for the same measure 
that is reported through multiple submission mechanisms, but data 
completeness would need to be achieved for each measure and associated 
submission mechanism.
    Comment: One commenter requested clarification on how the data 
completeness will be determined if reporting the same quality measures 
via multiple submission mechanisms, for example, if a clinician 
utilized two submission mechanisms to report the same measure, would 50 
percent data completeness need to be achieved for each submission 
mechanism or for the combined data submitted. Another commenter asked 
how CMS will take into consideration data that is submitted using the 
same submission mechanism, but using two different products or 
services, specifically data submitted from two different certified EHRs 
in a single performance period when clinicians switch EHRs mid-
performance year.
    Response: In the CY 2017 Quality Payment Program final rule, we 
finalized that for the quality performance category, an individual MIPS 
eligible clinician or group that submits data on quality measures via 
EHR, QCDR, qualified registry, claims, or a CMS-approved survey vendor 
for the CAHPS for MIPS survey will be assigned measure achievement 
points for 6 measures (1 outcome, or if an outcome measure is not 
available, another high priority measure and the next 5 highest scoring 
measures) as available and applicable, and we will receive applicable 
measure bonus points for all measures submitted that meet the bonus 
criteria (81 FR 77282 through 77301). Consistent with this policy, we 
would like to clarify that for performance periods beginning in 2019, 
if a MIPS eligible clinician or group reports for the quality 
performance category by using multiple instances of the same data 
submission mechanism (for example, multiple EHRs) then all the 
submissions would be scored, and the 6 quality measures with the 
highest performance (that is, the greatest number of measure 
achievement points) would be utilized for the quality performance 
category score. As noted above, if an individual MIPS eligible 
clinician or group submits the same measure through two different 
mechanisms, each submission would be calculated and scored separately. 
We do not have the ability to aggregate data on the same measure across 
multiple submission mechanisms. We would only count the submission that 
gives the clinician the higher score, thereby avoiding the double 
count. For example, if a MIPS eligible clinician submits performance 
data for Quality Measure 236, Controlling High Blood Pressure, using a 
registry and also through an EHR, these two submissions would be scored 
separately, and we would apply the submission with the higher score 
towards the quality performance score; we would not aggregated the 
score of the registry and EHR submission of the same measure. This 
approach decreases the likelihood of cumulative overcounting in the 
event that the submissions may have time or patient overlaps that may 
not be readily identifiable.
    Final Action: After consideration of the public comments received, 
we are finalizing our proposal at Sec.  414.1325(d) with modification. 
Specifically, due to operational reasons, and to allow for additional 
time to communicate how this policy intersects with out measure 
applicability policies, we are not finalizing this policy for the CY 
2019 performance period. For the CY 2018 performance period, we intend 
to continue implementing the submission mechanisms policies as 
finalized in the CY 2017 Quality Payment Program final rule (81 FR 
77094) that individual MIPS eligible clinicians and groups may elect to 
submit information via multiple submission mechanisms; however, they 
must use one submission mechanism per performance category. We are, 
however, finalizing our proposal beginning with the CY 2019 performance 
period. Thus, for purposes of the 2021 MIPS payment year and future 
years, beginning with performance periods occurring in 2019, individual 
MIPS eligible clinicians, groups, and virtual groups may submit data on 
measures and activities, as applicable, via multiple data submission 
mechanisms for a single performance category (specifically, the 
quality, improvement activities, or advancing care information 
performance category). Individual MIPS eligible clinicians and groups 
that have fewer than the required number of measures and activities 
applicable and available under one submission mechanism may submit data 
on additional measures and activities via one or more additional 
submission mechanisms, as necessary, provided that such measures and 
activities are applicable and available to them.
    We are finalizing our proposal with modification. Specifically, we 
are not finalizing our proposal for the CY 2018 performance period, and 
our previously finalized policies continue to apply for the CY 2018 
performance period. Thus, for the CY 2018 performance period, virtual 
groups may elect to submit information via multiple submission 
mechanisms; however, they must use the same identifier for all practice 
categories, and they may only use one submission mechanism per 
performance

[[Page 53626]]

category. We are, however, finalizing our proposal beginning with the 
CY 2019 performance period. Thus, beginning with the CY 2019 
performance period, virtual groups will be able to use multiple 
submission mechanisms for each performance category.
(2) Submission Deadlines
    In the CY 2017 Quality Payment Program final rule (81 FR 77097), we 
finalized submission deadlines by which all associated data for all 
performance categories must be submitted for the submission mechanisms 
described in this rule.
    As specified at Sec.  414.1325(f)(1), the data submission deadline 
for the qualified registry, QCDR, EHR, and attestation submission 
mechanisms is March 31 following the close of the performance period. 
The submission period will begin prior to January 2 following the close 
of the performance period, if technically feasible. For example, for 
performance periods occurring in 2018, the data submission period will 
occur prior to January 2, 2019, if technically feasible, through March 
31, 2019. If it is not technically feasible to allow the submission 
period to begin prior to January 2 following the close of the 
performance period, the submission period will occur from January 2 
through March 31 following the close of the performance period. In any 
case, the final deadline will remain March 31, 2019.
    At Sec.  414.1325(f)(2), we specified that for the Medicare Part B 
claims submission mechanism, data must be submitted on claims with 
dates of service during the performance period that must be processed 
no later than 60 days following the close of the performance period. 
Lastly, for the CMS Web Interface submission mechanism, at Sec.  
414.1325(f)(3), we specified that the data must be submitted during an 
8-week period following the close of the performance period that will 
begin no earlier than January 2, and end no later than March 31. For 
example, the CMS Web Interface submission period could span an 8-week 
timeframe beginning January 16 and ending March 13. The specific 
deadline during this timeframe will be published on the CMS Web site. 
We did not propose any changes to the submission deadlines in the CY 
2018 Quality Payment Program proposed rule.
b. Quality Performance Criteria
(1) Background
    Sections 1848(q)(1)(A)(i) and (ii) of the Act require the Secretary 
to develop a methodology for assessing the total performance of each 
MIPS eligible clinician according to performance standards and, using 
that methodology, to provide for a final score for each MIPS eligible 
clinician. Section 1848(q)(2)(A)(i) of the Act requires us to use the 
quality performance category in determining each MIPS eligible 
clinician's final score, and section 1848(q)(2)(B)(i) of the Act 
describes the measures and activities that must be specified under the 
quality performance category.
    The statute does not specify the number of quality measures on 
which a MIPS eligible clinician must report, nor does it specify the 
amount or type of information that a MIPS eligible clinician must 
report on each quality measure. However, section 1848(q)(2)(C)(i) of 
the Act requires the Secretary, as feasible, to emphasize the 
application of outcomes-based measures.
    Sections 1848(q)(1)(E) of the Act requires the Secretary to 
encourage the use of QCDRs, and section 1848(q)(5)(B)(ii)(I) of the Act 
requires the Secretary to encourage the use of CEHRT and QCDRs for 
reporting measures under the quality performance category under the 
final score methodology, but the statute does not limit the Secretary's 
discretion to establish other reporting mechanisms.
    Section 1848(q)(2)(C)(iv) of the Act generally requires the 
Secretary to give consideration to the circumstances of non-patient 
facing MIPS eligible clinicians and allows the Secretary, to the extent 
feasible and appropriate, to apply alternative measures or activities 
to such clinicians.
    As discussed in the CY 2017 Quality Payment Program final rule (81 
FR 77098 through 77099), we finalized MIPS quality criteria that focus 
on measures that are important to beneficiaries and maintain some of 
the flexibility from PQRS, while addressing several of the comments we 
received in response to the CY 2017 Quality Payment Program proposed 
rule and the MIPS and APMs RFI.
     To encourage meaningful measurement, we finalized allowing 
individual MIPS eligible clinicians and groups the flexibility to 
determine the most meaningful measures and data submission mechanisms 
for their practice.
     To simplify the reporting criteria, we aligned the 
submission criteria for several of the data submission mechanisms.
     To reduce administrative burden and focus on measures that 
matter, we lowered the required number of the measures for several of 
the data submission mechanisms, yet still required that certain types 
of measures, particularly outcome measures, be reported.
     To create alignment with other payers and reduce burden on 
MIPS eligible clinicians, we incorporated measures that align with 
other national payers.
     To create a more comprehensive picture of a practice's 
performance, we also finalized the use of all-payer data where 
possible.
    As beneficiary health is always our top priority, we finalized 
criteria to continue encouraging the reporting of certain measures such 
as outcome, appropriate use, patient safety, efficiency, care 
coordination, or patient experience measures. However, as discussed in 
the CY 2017 Quality Payment Program final rule (81 FR 77098), we 
removed the requirement for measures to span across multiple domains of 
the NQS. While we do not require that MIPS eligible clinicians select 
measures across multiple domains, we encourage them to do so.
(2) Contribution to Final Score
    For MIPS payment year 2019, the quality performance category will 
account for 60 percent of the final score, subject to the Secretary's 
authority to assign different scoring weights under section 
1848(q)(5)(F) of the Act. Section 1848(q)(2)(E)(i)(I)(aa) of the Act 
states that the quality performance category will account for 30 
percent of the final score for MIPS. However, section 
1848(q)(2)(E)(i)(I)(bb) of the Act stipulates that for the first and 
second years for which MIPS applies to payments, the percentage of the 
final score applicable for the quality performance category will be 
increased so that the total percentage points of the increase equals 
the total number of percentage points by which the percentage applied 
for the cost performance category is less than 30 percent. Section 
1848(q)(2)(E)(i)(II)(bb) of the Act requires that, for the transition 
year for which MIPS applies to payments, not more than 10 percent of 
the final score shall be based on the cost performance category. 
Furthermore, section 1848(q)(2)(E)(i)(II)(bb) of the Act states that, 
for the second year for which MIPS applies to payments, not more than 
15 percent of the final score shall be based on the cost performance 
category.
    In the CY 2017 Quality Payment Program final rule (81 FR 77100), we 
finalized at Sec.  414.1330(b) that, for MIPS payment years 2019 and 
2020, 60 percent and 50 percent, respectively, of

[[Page 53627]]

the MIPS final score will be based on the quality performance category. 
For the third and future years, 30 percent of the MIPS final score will 
be based on the quality performance category.
    As discussed in section II.C.6.d. of this final rule with comment 
period, we are not finalizing our proposal to weight the cost 
performance category at zero percent for the second MIPS payment year 
(2020) and are instead retaining the previously finalized cost 
performance category weight of 10 percent for that year. In accordance 
with section 1848(q)(5)(E)(i)(I)(bb) of the Act, for the first 2 years, 
the percentage of the MIPS final score that would otherwise be based on 
the quality performance category (that is, 30 percent) must be 
increased by the same number of percentage points by which the 
percentage based on the cost performance category is less than 30 
percent. We proposed to modify Sec.  414.1330(b)(2) to reweight the 
percentage of the MIPS final score based on the quality performance 
category for MIPS payment year 2020 as may be necessary to account for 
any reweighting of the cost performance category, if finalized (82 FR 
30037). Thus, since we are not finalizing our proposal to reweight the 
cost performance category to zero percent for MIPS payment year 2020, 
we are not finalizing our proposal to modify Sec.  414.1330(b)(2), as 
the performance in the quality performance category currently comprises 
50 percent of a MIPS eligible clinician's final score for MIPS payment 
year 2020, and no reweighting is necessary to account for the 
previously finalized cost performance category weight. We refer readers 
to section II.C.6.d. of this final rule with comment period for more 
information on the cost performance category.
    Section 1848(q)(5)(B)(i) of the Act requires the Secretary to treat 
any MIPS eligible clinician who fails to report on a required measure 
or activity as achieving the lowest potential score applicable to the 
measure or activity. Specifically, under our finalized scoring 
policies, an individual MIPS eligible clinician or group that reports 
on all required measures and activities could potentially obtain the 
highest score possible within the performance category, assuming they 
perform well on the measures and activities they report. An individual 
MIPS eligible clinician or group who does not submit data on a required 
measure or activity would receive a zero score for the unreported items 
in the performance category (in accordance with section 
1848(q)(5)(B)(i) of the Act). The individual MIPS eligible clinician or 
group could still obtain a relatively good score by performing very 
well on the remaining items, but a zero score would prevent the 
individual MIPS eligible clinician or group from obtaining the highest 
possible score within the performance category.
    The following is a summary of the public comments received on the 
``Contribution to Final Score'' proposal and our responses:
    Comment: Many commenters supported the policy to weight the quality 
performance category at 60 percent of the final score for the 2020 MIPS 
payment year. One commenter expressed appreciation for the proposal 
because it maintains consistency within the program, which facilitates 
easier implementation for upcoming years.
    Response: We appreciate the commenters' support. However, as noted 
above, we are not finalizing our proposal at Sec.  414.1330(b)(2) to 
provide that performance in the quality performance category will 
comprise 60 percent of a MIPS eligible clinician's final score for MIPS 
payment year 2020. We believe that by keeping our current policy to 
weight the quality performance period at 50 percent and the cost 
performance category at 10 percent will help ease the transition so 
that MIPS eligible clinicians can understand how they will be scored in 
future years under MIPS generally and the cost performance category in 
particular, as the cost performance category will be weighted at 30 
percent beginning with MIPS payment year 2021.
    Comment: One commenter did not support the policy to weight the 
quality performance category at 60 percent of the final score for the 
2020 MIPS payment year. Instead, the commenter recommended that CMS 
retain the previously finalized weighting for the quality performance 
category of 50 percent for the 2020 MIPS payment year. The commenter 
explained that since the 2021 MIPS payment year will require a cost 
performance category weighting of 30 percent, they recommended that CMS 
not retreat from progressing toward that amount in the intervening 
year.
    Response: We appreciate the commenter's recommendation and note 
that we are not finalizing the cost performance category weighting at 
zero percent toward the final score for the 2020 MIPS payment year. 
Further, the percentage of the MIPS final score based on the quality 
performance category for MIPS payment year 2020 will be 50 percent in 
accordance with section 1848(q)(5)(E)(i)(I)(bb) of the Act. We refer 
readers to section II.C.6.d. of this final rule with comment period for 
more information on the cost performance category.
    Comment: One commenter requested clarification on the policy to 
weight the quality performance category at 60 percent of the final 
score for the 2020 MIPS payment year instead of 50 percent. The 
commenter requested clarification as to which performance category the 
10 percent difference would apply if the quality performance category 
was weighted at 50 percent in the 2020 MIPS payment year.
    Response: As previously noted in this final rule with comment 
period, for the 2020 MIPS payment year, the quality performance 
category will be weighted at 50 percent. The 10 percent difference will 
be applied to the cost performance category.
    Comment: A few commenters urged CMS to reconsider the proposal to 
weight the quality performance category at 60 percent of the final 
score for the 2020 MIPS payment year for non-patient facing MIPS 
eligible clinicians. One commenter noted that the quality performance 
category accounts for 85 percent of the total score for pathologists, 
and placing this much weight on the quality performance category puts 
pathologists at an unfair disadvantage given the lack of reportable 
measures. The commenter recommended that the improvement activity 
performance category be weighted more heavily at a 50 percent weight 
and that the quality performance category receive a 50 percent weight. 
Another commenter indicated that it was not possible for non-patient 
facing MIPS eligible clinicians to achieve a score higher than 40 
percent, in the quality performance category, given a lack of measures 
and given that those measures that are applicable are only worth 3 
points. While this score allows them to avoid a penalty, the commenter 
noted it precludes them from achieving a bonus. Thus, the commenter 
recommended that CMS reweight the quality performance category for non-
patient facing MIPS eligible clinicians so that they can receive a 
score of 70 percent or higher. This would give non-patient facing MIPS 
eligible clinicians motivation for improvement as well as encourage 
them to continue to participate in the Quality Payment Program should 
it become voluntary.
    Response: As previously noted in this final rule with comment 
period, we are not finalizing our proposal to reweight the quality 
performance to 60 percent of the final score or the cost performance 
category to zero percent of the final score for the 2020 MIPS payment 
year.

[[Page 53628]]

Therefore, we are keeping our previously finalized policy to weight the 
quality performance category at 50 percent and the cost performance 
category at 10 percent for the 2020 MIPS payment year. It is important 
to note that for the 2021 MIPS payment year that the quality 
performance category will be 30 percent of the final score, and the 
cost performance category will be 30 percent of the final score as 
required by statute. We cannot weight the improvement activities 
performance category more heavily as suggested because section 
1848(q)(5)(E)(i)(III) of the Act specifies that the improvement 
activities performance category will account for 15 percent of the 
final score and was codified as such at Sec.  414.1355. Regarding the 
comment on applicable measures being worth less points, we note that 
non-patient facing MIPS eligible clinicians may report on a specialty-
specific measure set (which may have fewer than the required six 
measures) or may report through a QCDR that can report QCDR measures in 
order to earn the full points in the quality performance category.
    Final Action: After consideration of the public comments, we are 
not finalizing our proposal at Sec.  414.1330(b)(2) to provide that 
performance in the quality performance category will comprise 60 
percent of a MIPS eligible clinician's final score for MIPS payment 
year 2020. Rather we will be maintaining our previously finalized 
policy at Sec.  414.1330(b)(2) to provide that the performance in the 
quality performance category will comprise 50 percent of a MIPS 
eligible clinician's final score for MIPS payment year 2020.
(3) Quality Data Submission Criteria
(a) Submission Criteria
(i) Submission Criteria for Quality Measures Excluding Groups Reporting 
via the CMS Web Interface and the CAHPS for MIPS Survey
    In the CY 2017 Quality Payment Program final rule (81 FR 77114), we 
finalized at Sec.  414.1335(a)(1) that individual MIPS eligible 
clinicians submitting data via claims and individual MIPS eligible 
clinicians and groups submitting data via all mechanisms (excluding the 
CMS Web Interface and the CAHPS for MIPS survey) are required to meet 
the following submission criteria. For the applicable period during the 
performance period, the individual MIPS eligible clinician or group 
will report at least six measures, including at least one outcome 
measure. If an applicable outcome measure is not available, the 
individual MIPS eligible clinician or group will be required to report 
one other high priority measure (appropriate use, patient safety, 
efficiency, patient experience, and care coordination measures) in lieu 
of an outcome measure. If fewer than six measures apply to the 
individual MIPS eligible clinician or group, then the individual MIPS 
eligible clinician or group would be required to report on each measure 
that is applicable. We defined ``applicable'' to mean measures relevant 
to a particular MIPS eligible clinician's services or care rendered. As 
discussed in section II.C.7.a.(2) of this final rule with comment 
period, we will only make determinations as to whether a sufficient 
number of measures are applicable for claims-based and registry 
submission mechanisms; we will not make this determination for EHR and 
QCDR submission mechanisms, for example.
    Alternatively, the individual MIPS eligible clinician or group will 
report one specialty measure set, or the measure set defined at the 
subspecialty level, if applicable. If the measure set contains fewer 
than six measures, MIPS eligible clinicians will be required to report 
all available measures within the set. If the measure set contains six 
or more measures, MIPS eligible clinicians will be required to report 
at least six measures within the set. Regardless of the number of 
measures that are contained in the measure set, MIPS eligible 
clinicians reporting on a measure set will be required to report at 
least one outcome measure or, if no outcome measures are available in 
the measure set, the MIPS eligible clinician will report another high 
priority measure (appropriate use, patient safety, efficiency, patient 
experience, and care coordination measures) within the measure set in 
lieu of an outcome measure. MIPS eligible clinicians may choose to 
report measures in addition to those contained in the specialty measure 
set and will not be penalized for doing so, provided that such MIPS 
eligible clinicians follow all requirements discussed here.
    In accordance with Sec.  414.1335(a)(1)(ii), individual MIPS 
eligible clinicians and groups will select their measures from either 
the set of all MIPS measures listed or referenced in Table A of the 
Appendix in this final rule with comment period or one of the specialty 
measure sets listed in Table B of the Appendix in this final rule with 
comment period. We note that some specialty measure sets include 
measures grouped by subspecialty; in these cases, the measure set is 
defined at the subspecialty level. Previously finalized quality 
measures may be found in the CY 2017 Quality Payment Program final rule 
(81 FR 77558 through 77816).
    We also finalized the definition of a high priority measure at 
Sec.  414.1305 to mean an outcome, appropriate use, patient safety, 
efficiency, patient experience, or care coordination quality measure. 
Except as discussed in section II.C.6.b.(3)(a) of this final rule with 
comment period with regard to the CMS Web Interface and the CAHPS for 
MIPS survey, we did not propose any changes to the submission criteria 
or definitions established for measures in the proposed rule.
    In the CY 2017 Quality Payment Program final rule (81 FR 77114), we 
solicited comments regarding adding a requirement to our finalized 
policy that patient-facing MIPS eligible clinicians would be required 
to report at least one cross-cutting measure in addition to the high 
priority measure requirement for further consideration for the Quality 
Payment Program Year 2 and future years. For clarification, we consider 
a cross-cutting measure to be any measure that is broadly applicable 
across multiple clinical settings and individual MIPS eligible 
clinicians or groups within a variety of specialties. We specifically 
requested feedback on how we could construct a cross-cutting measure 
requirement that would be most meaningful to MIPS eligible clinicians 
from different specialties and that would have the greatest impact on 
improving the health of populations. We refer readers to the CY 2018 
Quality Payment Program proposed rule (82 FR 30038 through 30039) for a 
full discussion of the comments received and responses provided.
    Except as discussed in section II.C.6.b.(3)(a)(iii) of this final 
rule with comment period with regard to the CAHPS for MIPS survey, we 
did not propose any changes to the submission criteria for quality 
measures. We solicited additional feedback on meaningful ways to 
incorporate cross-cutting measurement into MIPS and the Quality Payment 
Program generally. We received several comments regarding incorporating 
cross-cutting measurements into the Quality Payment Program and will 
take them into consideration in future rulemaking.
(ii) Submission Criteria for Quality Measures for Groups Reporting via 
the CMS Web Interface
    In the CY 2017 Quality Payment Program final rule (81 FR 77116), we 
finalized at Sec.  414.1335(a)(2) the following criteria for the 
submission of data on quality measures by registered groups of 25 or 
more eligible clinicians

[[Page 53629]]

who want to report via the CMS Web Interface. For the applicable 12-
month performance period, the group would be required to report on all 
measures included in the CMS Web Interface completely, accurately, and 
timely by populating data fields for the first 248 consecutively ranked 
and assigned Medicare beneficiaries in the order in which they appear 
in the group's sample for each module or measure. If the sample of 
eligible assigned beneficiaries is less than 248, then the group would 
report on 100 percent of assigned beneficiaries. A group would be 
required to report on at least one measure for which there is Medicare 
patient data. Groups reporting via the CMS Web Interface are required 
to report on all of the measures in the set. Any measures not reported 
would be considered zero performance for that measure in our scoring 
algorithm. Specifically, we proposed to revise Sec.  414.1335(a)(2) to 
clarify that the CMS Web Interface criteria applies only to groups of 
25 or more eligible clinicians (82 FR 30039). As previously finalized 
at Sec.  414.1335(a)(2)(i), groups using the CMS Web Interface must 
report on all measures included in the CMS Web Interface and report on 
the first 248 consecutively ranked beneficiaries in the sample for each 
measure or module.
    In the CY 2017 Quality Payment Program final rule (81 FR 77116), we 
finalized to continue to align the 2019 CMS Web Interface beneficiary 
assignment methodology with the attribution methodology for two of the 
measures that were formerly in the VM: the acute and chronic composite 
measures of Agency for Healthcare Research and Quality (AHRQ) 
Prevention Quality Indicators (PQIs) discussed in the CY 2017 Quality 
Payment Program proposed rule (81 FR 28192) and total per capita cost 
for all attributed beneficiaries discussed in the CY 2017 Quality 
Payment Program proposed rule (81 FR 28196). When establishing MIPS, we 
also finalized a modified attribution process to update the definition 
of primary care services and to adapt the attribution to different 
identifiers used in MIPS. These changes are discussed in the CY 2017 
Quality Payment Program proposed rule (81 FR 28196).
    We clarify that the attribution methodology for the CMS Web 
Interface implemented under MIPS is similar to the attribution 
methodology implemented under the Physician Quality Reporting System 
(PQRS) Group Practice Reporting Option (GPRO) Web Interface, which 
utilizes a two-step attribution process to associate beneficiaries with 
TINs during the period in which performance is assessed. The process 
attributes a beneficiary to a TIN that bills the plurality of primary 
care services for that beneficiary. In order to conduct attribution for 
the CMS Web Interface, we utilize retrospective assignment to identify 
beneficiaries eligible for sampling and identify the beneficiary claims 
that will be utilized for the calculations of cost. Beneficiary 
assignment for groups is based on a 10-month period (between January 
and October) and determined retrospectively after the month of October 
for the applicable performance period. We note that it is not 
operationally feasible for us to utilize a period longer than 10 
months, to assess claims data for beneficiary assignment for a 
performance period.
    Lastly, we note that groups reporting via the CMS Web Interface may 
also report the CAHPS for MIPS survey and receive bonus points for 
submitting that measure. We did not propose any changes to the 
submission criteria for quality measures for groups reporting via the 
CMS Web Interface in the proposed rule.
    The following is a summary of the public comments received on the 
``Submission Criteria for Quality Measures for Groups Reporting via the 
CMS Web Interface'' proposal and our responses:
    Comment: One commenter suggested that CMS allow groups with fewer 
than 25 eligible clinicians (such as 2 or more eligible clinicians in a 
group) to use CMS Web Interface reporting. The commenter was concerned 
that the Quality Payment Program is more limiting than PQRS with regard 
to available submission mechanisms.
    Response: The CMS Web Interface has been limited to groups of 25 or 
more eligible clinicians because smaller groups have not been able to 
meet the data submission requirements on the sample of the Medicare 
Part B patients we provide. We would like to clarify that we have made 
available the same submission mechanisms for the Quality Payment 
Program that were available for PQRS. In addition, we are finalizing 
our proposal to revise Sec.  414.1325(d) for purposes of the 2021 MIPS 
payment year and future years to allow individual MIPS eligible 
clinicians and groups to submit measures and activities, as applicable, 
via as many submission mechanisms as necessary to meet the requirements 
of the quality, improvement activities, or advancing care information 
performance categories. We refer readers to section II.C.6.a.(1) of 
this final rule with comment period for more information on submission 
mechanisms.
    Final Action: After consideration of the public comments, we are 
finalizing our proposal at Sec.  414.1335(a)(2) to clarify that the CMS 
Web Interface criteria applies only to group of 25 or more eligible 
clinicians. As previously finalized at Sec.  414.1335(a)(2)(i), the 
group must report on the first 248 consecutively ranked beneficiaries 
in the sample for each measure or module.
(iii) Performance Criteria for Quality Measures for Groups Electing To 
Report Consumer Assessment of Healthcare Providers and Systems (CAHPS) 
for MIPS Survey
    In the CY 2017 Quality Payment Program final rule (81 FR 77100), we 
finalized at Sec.  414.1335(a)(3) the following criteria for the 
submission of data on the CAHPS for MIPS survey by registered groups 
via CMS-approved survey vendor: For the applicable 12-month performance 
period, a group that wishes to voluntarily elect to participate in the 
CAHPS for MIPS survey measure must use a survey vendor that is approved 
by CMS for a particular performance period to transmit survey measures 
data to CMS. The CAHPS for MIPS survey counts for one measure towards 
the MIPS quality performance category and, as a patient experience 
measure, also fulfills the requirement to report at least one high 
priority measure in the absence of an applicable outcome measure. In 
addition, groups that elect this data submission mechanism must select 
an additional group data submission mechanism (that is, qualified 
registries, QCDRs, EHR, etc.) in order to meet the data submission 
criteria for the MIPS quality performance category. The CAHPS for MIPS 
survey will count as one patient experience measure, and the group will 
be required to submit at least five other measures through one other 
data submission mechanism. A group may report any five measures within 
MIPS plus the CAHPS for MIPS survey to achieve the six measures 
threshold. We did not propose any changes to the performance criteria 
for quality measures for groups electing to report the CAHPS for MIPS 
survey in the proposed rule.
    In the CY 2017 Quality Payment Program final rule (see 81 FR 
77120), we finalized retaining the CAHPS for MIPS survey administration 
period that was utilized for PQRS of November to February. However, 
this survey administration period has become operationally problematic 
for the administration of MIPS. In order to compute scoring, we must 
have the

[[Page 53630]]

CAHPS for MIPS survey data earlier than the current survey 
administration period deadline allows. Therefore, we proposed for the 
Quality Payment Program Year 2 and future years that the survey 
administration period would, at a minimum, span over 8 weeks and would 
end no later than February 28th following the applicable performance 
period (82 FR 30040). In addition, we proposed to further specify the 
start and end timeframes of the survey administration period through 
our normal communication channels.
    In addition, as discussed in the CY 2017 Quality Payment Program 
final rule (81 FR 77116), we anticipated exploring the possibility of 
updating the CAHPS for MIPS survey under MIPS, specifically not 
finalizing all of the proposed Summary Survey Measures (SSMs). The 
CAHPS for MIPS survey currently consists of the core CAHPS Clinician & 
Group (CG-CAHPS) Survey developed by the Agency for Healthcare Research 
and Quality (AHRQ), plus additional survey questions to meet CMS's 
program needs. We proposed for the Quality Payment Program Year 2 and 
future years to remove two SSMs, specifically, ``Helping You to Take 
Medication as Directed'' and ``Between Visit Communication'' from the 
CAHPS for MIPS survey (82 FR 30040). We proposed to remove the SSM 
entitled ``Helping You to Take Medication as Directed'' due to low 
reliability. In 2014 and 2015, the majority of groups had very low 
reliability on this SSM. Furthermore, based on analyses conducted of 
SSMs in an attempt to improve their reliability, removing questions 
from this SSM did not result in any improvements in reliability. The 
SSM, ``Helping You to Take Medication as Directed,'' has also never 
been a scored measure with the Medicare Shared Savings Program CAHPS 
for Accountable Care Organizations (ACOs) Survey. We refer readers to 
the CY 2014 Physician Fee Schedule final rule for a discussion on the 
CAHPS for ACOs survey scoring (79 FR 67909 through 67910) and measure 
tables (79 FR 67916 through 67917). The SSM entitled ``Between Visit 
Communication'' currently contains only one question. This question 
could also be considered related to other SSMs entitled: ``Care 
Coordination'' or ``Courteous and Helpful Office Staff,'' but does not 
directly overlap with any of the questions under that SSM. However, we 
proposed to remove this SSM in order to maintain consistency with the 
Medicare Shared Savings Program which, utilizes the CAHPS for ACOs 
Survey. The SSM entitled ``Between Visit Communication'' has never been 
a scored measure with the Medicare Shared Savings Program CAHPS for 
ACOs Survey. We refer readers to section II.C.6.g. for the discussion 
of the CAHPS for ACOs survey.
    In addition to public comments we received, we also took into 
consideration analysis we conducted before finalizing this provision. 
Specifically, we reviewed the findings of the CAHPS for ACOs survey 
pilot, which was administered from November 2016 through February 2017. 
The CAHPS for ACOs survey pilot utilized a survey instrument which did 
not contain the two SSMs that we proposed for removal from the CAHPS 
for MIPS survey. For more information on the other SSMs within the 
CAHPS for MIPS survey, please see the explanation of the CAHPS for PQRS 
survey in the CY 2016 PFS final rule with comment period (80 FR 71142 
through 71143).

 Table 4--Summary Survey Measures (SSMs) Included in the CAHPS for MIPS
                                 Survey
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Getting Timely Care, Appointments, and Information.
How Well Providers Communicate.
Patient's Rating of Provider.
Access to Specialists.
Health Promotion and Education.
Shared Decision-Making.
Health Status and Functional Status.
Courteous and Helpful Office Staff.
Care Coordination.
Stewardship of Patient Resources.
------------------------------------------------------------------------

    We sought comment on expanding the patient experience data 
available for the CAHPS for MIPS survey (82 FR 30040 through 30401). 
Currently, the CAHPS for MIPS survey is available for groups to report 
under the MIPS. The patient experience survey data that is available on 
Physician Compare is highly valued by patients and their caregivers as 
they evaluate their health care options. However, in user testing with 
patients and caregivers in regard to the Physician Compare Web site, 
the users regularly request more information from patients like them in 
their own words. Patients regularly request that we include narrative 
reviews of individual clinicians and groups on the Web site. AHRQ is 
fielding a beta version of the CAHPS Patient Narrative Elicitation 
Protocol (https://www.ahrq.gov/cahps/surveys-guidance/item-sets/elicitation/index.html). This includes five open-ended questions 
designed to be added to the CG CAHPS survey, after which the CAHPS for 
MIPS survey is modeled. These five questions have been developed and 
tested in order to capture patient narratives in a scientifically 
grounded and rigorous way, setting it apart from other patient 
narratives collected by various health systems and patient rating 
sites. More scientifically rigorous patient narrative data would not 
only greatly benefit patients in their decision for healthcare, but it 
would also greatly aid individual MIPS eligible clinicians and groups 
as they assess how their patients experience care. We sought comment on 
adding these five open-ended questions to the CAHPS for MIPS survey in 
future rulemaking. Beta testing is an ongoing process, and we 
anticipate reviewing the results of that testing in collaboration with 
AHRQ before proposing changes to the CAHPS for MIPS survey.
    We are requiring, where possible, all-payer data for all reporting 
mechanisms, yet certain reporting mechanisms are limited to Medicare 
Part B data. Specifically, the CAHPS for MIPS survey currently relies 
on sampling protocols based on Medicare Part B billing; therefore, only 
Medicare Part B beneficiaries are sampled through that methodology. We 
requested comments on ways to modify the methodology to assign and 
sample patients using data from other payers for reporting mechanisms 
that are currently limited to Medicare Part B data (82 FR 30041). In 
particular, we sought comment on the ability of groups to provide 
information on the patients to whom they provide care during a calendar 
year, whether it would be possible to identify a list of patients seen 
by individual clinicians in the group, and what type of patient contact 
information groups would be able to provide. Further, we sought comment 
on the challenges groups may anticipate in trying to provide this type 
of information, especially for vulnerable beneficiary populations, such 
as those lacking stable housing. We also sought comment on EHR vendors' 
ability to provide information on the patients who receive care from 
their client groups.
    The following is a summary of the public comments received on the 
``Performance Criteria for Quality Measures for Groups Electing to 
Report the CAHPS for MIPS Survey'' proposals and our responses:
    Comment: A few commenters supported removing the 2 SSMs, ``Helping 
You to Take Medication as Directed'' and ``Between Visit 
Communication'' from CAHPS for MIPS for the 2018 MIPS performance 
period and future MIPS performance periods. The commenters recommended 
that CMS communicate all changes made to the CAHPS for MIPS survey well 
in advance of the annual registration

[[Page 53631]]

deadline. While supportive of CMS' proposal to remove these 2 SSMs, one 
commenter urged CMS to replace the ``Helping You to Take Medication as 
Directed'' module with a reliable way to measure patient experience for 
patients as part of understanding their medications. Finally, one 
commenter urged CMS to make the survey even shorter, stating that it is 
still significantly too long to gain a large enough adoption rate among 
patients and needs to be reduced further to increase completion rates.
    Response: We thank the commenters for their support and will make 
every effort to continue to communicate changes to the CAHPS for MIPS 
survey. We also appreciate the commenters' suggestion to replace the 
``Helping You to Take Medication as Directed'' SSM with a reliable way 
to measure patients' understanding of their medications, as well as the 
suggestion to reduce the number of questions in the CAHPS for MIPS 
survey, and will consider these suggestions for future years of the 
CAHPS for MIPS survey. We are finalizing for the Quality Payment 
Program Year 2 and future years to remove two SSMs, specifically, 
``Helping You to Take Medication as Directed'' and ``Between Visit 
Communication'' from the CAHPS for MIPS survey.
    Comment: Several commenters did not support the proposal to remove 
the 2 SSMs without alternative domains or better patient experience or 
patient-reported outcomes measures to replace them and urged us to 
leave these SSMs in the survey at this time. Commenters noted that 
although the ``Between Visit Communication'' measure is related to 2 
other SSMs (``Care Coordination'' and ``Courteous and Helpful Office 
Staff''), these measures do not entirely overlap, and poor 
communication between visits can have serious consequences. The 
commenters also expressed concern that the ``Helping You to Take 
Medication as Directed'' SSM is needed to continue to capture safe and 
appropriate medication use as a domain of the CAHPS for MIPS survey. 
One commenter expressed concern that removal of the SSM is premature 
and encouraged us to improve this SSM instead of removing it entirely, 
urging us to retain the SSM and capture this information within both 
the CAHPS for MIPS and the CAHPS for ACOs surveys if necessary. Another 
commenter recommended that CMS keep the current CAHPS format which they 
noted provides important feedback on key areas such as timely 
appointments, easy access to information, and good communication with 
healthcare providers.
    Response: We acknowledge the commenters' concerns with respect to 
removing the ``Between Visit Communication'' and ``Helping You to Take 
Medication as Directed'' SSMs. We would like to note that the Shared 
Savings Program piloted tested a revised CAHPS survey that did not 
include these two SSMs, and we have reviewed the results of that 
survey. Results from the pilot study suggest that administration of the 
shortened version of the survey (that is, the pilot survey) is likely 
to result in improvements in overall response rates. Findings show that 
the response rate to the pilot survey was 3.4 percentage points higher 
than the response rate to the Reporting Year (RY) 2016 CAHPS for ACOs 
survey among ACOs participating in the pilot study. Increases in 
response rates tended to be larger among ACOs that had lower response 
rates in the prior year. In addition, after accounting for survey 
questions that were removed from the pilot survey, the average survey 
responses for ACOs who participated in the pilot study were mostly 
similar across the two survey versions (pilot and RY 2016). Based on 
results of the piloted CAHPS survey, we recommend the removal of the 
two SSMs ``Between Visit Communication'' and ``Helping You to Take 
Medications as Directed''. Further, the SSM, ``Between Visit 
Communication,'' currently contains only one question. This question 
could also be considered related to other SSMs entitled: ``Care 
Coordination'' or ``Courteous and Helpful Office Staff,'' but does not 
directly overlap with any of the questions under that SSM. As for the 
SSM, ``Helping You to Take Medication as Directed,'' this SSM has had 
low reliability. However, we will continue to look at ways to further 
improve the CAHPS for MIPS survey including exploring new questions and 
domains of patient experience. We are finalizing for the Quality 
Payment Program Year 2 and future years to remove two SSMs, 
specifically, ``Helping You to Take Medication as Directed'' and 
``Between Visit Communication'' from the CAHPS for MIPS survey.
    Comment: A few commenters supported the proposal to reduce the 
minimum fielding period for CAHPS for MIPS from 4 months to 2 months in 
the 2018 MIPS performance period to allow CMS to have adequate time to 
collect the data needed to administer the MIPS program. One commenter 
urged CMS to explore additional ways to improve the survey in terms of 
the survey administration time frame, frequency of results, and the 
length of the survey and its administration, which is often well after 
the patient's visit.
    Response: We plan to consider additional ways to improve the survey 
in regards to the timeframe for administering the survey, frequency of 
the results, as well as the survey instrument and its administration. 
We are finalizing that for the Quality Payment Program Year 2 and 
future years the survey administration period would span over a minimum 
of 8 weeks to a maximum of 17 weeks and would end no later than 
February 28th following the applicable performance period. In addition, 
we are finalizing to further specify the start and end timeframes of 
the survey administration period through our normal communication 
channels.
    Comment: A few commenters did not support the proposal to change 
the minimum fielding period for CAHPS for MIPS, expressing concern that 
2 months of data is inadequate for a meaningful assessment of the 
patient experience. One commenter expressed concern that the cost to 
engage a survey vendor for a relatively short period and for 
potentially low returns may limit the value of participation, 
especially if the cost is in addition to costs for the mechanisms to 
support the other 5 quality measures. Commenters encouraged CMS to 
field the CAHPS for MIPS survey for at least 10 to 14 weeks--or to 
select 12 weeks in alignment with existing CAHPS guidelines--in order 
to improve the patient response rate and avoid unintentionally 
excluding patients who have a more difficult time responding within the 
shortened response period.
    Response: We appreciate the commenters' concern that 2 months of 
data is inadequate for a meaningful assessment of patient experience 
and the recommendation to field the CAHPS for MIPS survey for at least 
10 to 14 weeks. We would like to clarify that the proposal was for the 
survey administration, at a minimum, to span over 8 weeks. We believe 
that an 8 week minimum is adequate for the meaningful assessment of the 
patient experience because it provides sufficient time for the 
beneficiaries to respond to the survey. With respect to the 2018 CAHPS 
for MIPS survey, we anticipate that the survey administration period 
will be longer than the minimum 8 weeks and note that we will specify 
the start and end timeframes of the survey administration period 
through our normal communication channels. Further, this policy will 
allow us the flexibility to adjust the survey administration period to 
meet future operational needs, as well

[[Page 53632]]

as any newly identified adjustments to the survey administration period 
that would result in improvements, such as response rates. We are 
finalizing that for the Quality Payment Program Year 2 and future years 
the survey administration period would, span over a minimum of 8 weeks 
to a maximum of 17 weeks and end no later than February 28th following 
the applicable performance period. We refer readers to section 
II.C.6.a. of this final rule with comment period for more information 
on submission mechanisms.
    Final Action: After consideration of the public comments, we are 
finalizing that for the Quality Payment Program Year 2 and future years 
the survey administration period would span over a minimum of 8 weeks 
to a maximum of 17 weeks and would end no later than February 28th 
following the applicable performance period. In addition, we are 
finalizing to further specify the start and end timeframes of the 
survey administration period through our normal communication channels. 
Further, we are finalizing for the Quality Payment Program Year 2 and 
future years to remove two SSMs, specifically, ``Helping You to Take 
Medication as Directed'' and ``Between Visit Communication'' from the 
CAHPS for MIPS survey.
(b) Data Completeness Criteria
    In the CY 2017 Quality Payment Program final rule (81 FR 77125), we 
finalized data completeness criteria for the transition year and MIPS 
payment year 2020. We finalized at Sec.  414.1340 the data completeness 
criteria that follows for performance periods occurring in 2017.
     Individual MIPS eligible clinicians or groups submitting 
data on quality measures using QCDRs, qualified registries, or via EHR 
must report on at least 50 percent of the individual MIPS eligible 
clinician or group's patients that meet the measure's denominator 
criteria, regardless of payer, for the performance period. In other 
words, for these submission mechanisms, we expect to receive quality 
data for both Medicare and non-Medicare patients. For the transition 
year, MIPS eligible clinicians whose measures fall below the data 
completeness threshold of 50 percent would receive 3 points for 
submitting the measure.
     Individual MIPS eligible clinicians submitting data on 
quality measures data using Medicare Part B claims, would report on at 
least 50 percent of the Medicare Part B patients seen during the 
performance period to which the measure applies. For the transition 
year, MIPS eligible clinicians whose measures fall below the data 
completeness threshold of 50 percent would receive 3 points for 
submitting the measure.
     Groups submitting quality measures data using the CMS Web 
Interface or a CMS-approved survey vendor to report the CAHPS for MIPS 
survey must meet the data submission requirements on the sample of the 
Medicare Part B patients that CMS provides.
    In addition, we finalized an increased data completeness threshold 
of 60 percent for MIPS for performance periods occurring in 2018 for 
data submitted on quality measures using QCDRs, qualified registries, 
via EHR, or Medicare Part B claims. We noted that we anticipate we will 
propose to increase these thresholds for data submitted on quality 
measures using QCDRs, qualified registries, via EHR, or Medicare Part B 
claims for performance periods occurring in 2019 and onward.
    We proposed to modify the previously established data completeness 
criteria for MIPS payment year 2020 (82 FR 30041 through 30042). 
Specifically, we proposed to provide an additional year for individual 
MIPS eligible clinicians and groups to gain experience with MIPS before 
increasing the data completeness thresholds for data submitted on 
quality measures using QCDRs, qualified registries, via EHR, or 
Medicare Part B claims. We noted concerns about the unintended 
consequences of accelerating the data completeness threshold so 
quickly, which may jeopardize MIPS eligible clinicians' ability to 
participate and perform well under the MIPS, particularly those 
clinicians who are least experienced with MIPS quality measure data 
submission. We wanted to ensure that an appropriate yet achievable 
level of data completeness is applied to all MIPS eligible clinicians. 
We continue to believe it is important to incorporate higher data 
completeness thresholds in future years to ensure a more accurate 
assessment of a MIPS eligible clinician's performance on quality 
measures and to avoid any selection bias. Therefore, we proposed a 60 
percent data completeness threshold for MIPS payment year 2021. We 
strongly encouraged all MIPS eligible clinicians to perform the quality 
actions associated with the quality measures on their patients. The 
data submitted for each measure is expected to be representative of the 
individual MIPS eligible clinician's or group's overall performance for 
that measure. The data completeness threshold of less than 100 percent 
is intended to reduce burden and accommodate operational issues that 
may arise during data collection during the initial years of the 
program. We provided this notice to MIPS eligible clinicians so that 
they can take the necessary steps to prepare for higher data 
completeness thresholds in future years.
    Therefore, we proposed to revise the data completeness criteria for 
the quality performance category at Sec.  414.1340(a)(2) to provide 
that MIPS eligible clinicians and groups submitting quality measures 
data using the QCDR, qualified registry, or EHR submission mechanism 
must submit data on at least 50 percent of the individual MIPS eligible 
clinician's or group's patients that meet the measure's denominator 
criteria, regardless of payer, for MIPS payment year 2020. We also 
proposed to revise the data completeness criteria for the quality 
performance category at Sec.  414.1340(b)(2) to provide that MIPS 
eligible clinicians and groups submitting quality measures data using 
Medicare Part B claims, must submit data on at least 50 percent of the 
applicable Medicare Part B patients seen during the performance period 
to which the measure applies for MIPS payment year 2020. We further 
proposed at Sec.  414.1340(a)(3), that MIPS eligible clinicians and 
groups submitting quality measures data using the QCDR, qualified 
registry, or EHR submission mechanism must submit data on at least 60 
percent of the individual MIPS eligible clinician or group's patients 
that meet the measure's denominator criteria, regardless of payer, for 
MIPS payment year 2021. We also proposed at Sec.  414.1340(b)(3), that 
MIPS eligible clinicians and groups submitting quality measures data 
using Medicare Part B claims, must submit data on at least 60 percent 
of the applicable Medicare Part B patients seen during the performance 
period to which the measure applies for MIPS payment year 2021. We 
noted that we anticipate for future MIPS payment years we will propose 
to increase the data completeness threshold for data submitted using 
QCDRs, qualified registries, EHR submission mechanisms, or Medicare 
Part B claims. As MIPS eligible clinicians gain experience with the 
MIPS, we would propose to steadily increase these thresholds for future 
years through rulemaking. In addition, we sought comment on what data 
completeness threshold should be established for future years.
    In the CY 2017 Quality Payment Program final rule (81 FR 77125 
through 77126), we finalized our approach of including all-payer data 
for the QCDR, qualified registry, and EHR submission mechanisms because 
we believed this approach provides a more complete picture of each MIPS 
eligible clinician's

[[Page 53633]]

scope of practice and provides more access to data about specialties 
and subspecialties not currently captured in PQRS. In addition, those 
clinicians who utilize the QCDR, qualified registry, or EHR data 
submission methods must contain a minimum of one quality measure for at 
least one Medicare patient. We did not propose any changes to these 
policies. As noted in the CY 2017 Quality Payment Program final rule, 
those MIPS eligible clinicians who fall below the data completeness 
thresholds will receive 3 points for the specific measures that fall 
below the data completeness threshold in the transition year of MIPS 
only. For the Quality Payment Program Year 2, we proposed that MIPS 
eligible clinicians would receive 1 point for measures that fall below 
the data completeness threshold, with an exception for small practices, 
which would still receive 3 points for measures that fail data 
completeness. We refer readers to section II.C.6.b.(3) of this final 
rule with comment period for our finalized policies on instances when 
MIPS eligible clinicians' measures fall below the data completeness 
threshold.
    The following is a summary of the public comments received on the 
``Data Completeness Criteria'' proposals and our responses:
    Comment: Several commenters expressed support for our proposal to 
increase the data completeness threshold to 60 percent for the 2021 
MIPS payment year.
    Response: We appreciate the commenters' support and are finalizing 
this proposal.
    Comment: Several commenters urged CMS to not finalize an increase 
in the data completeness threshold for the 2021 MIPS payment year or 
future payment years. Commenters noted that constant changing in 
reporting requirements creates administrative challenges for eligible 
clinicians and their staff. Other commenters observed that a higher 
threshold of data completeness requires a significant amount of 
technical and administrative coordination which can take several months 
to properly validate, both for MIPS eligible clinicians in larger 
practices and those in small and rural practices.
    Response: We understand the commenters' concerns but believe it is 
important to incorporate higher thresholds to ensure a more accurate 
assessment of a MIPS eligible clinician's performance on the quality 
measures and to avoid any selection bias. Therefore, we are not 
finalizing our proposal to decrease the data completeness threshold to 
50 percent for the 2020 MIPS payment year and are instead retaining the 
previously finalized data completeness threshold of 60 percent that 
year. In addition, we are finalizing our proposal to increase the data 
completeness threshold to 60 percent for MIPS payment year 2021.
    Comment: Many commenters supported the proposal to apply the data 
completeness criteria that was previously finalized for the CY 2017 
performance period to the CY 2018 performance period because they 
believed that it would help create stability within the quality 
performance category, would enable MIPS eligible clinicians and groups 
to gain additional experience reporting on quality measures and make 
improvements, and would enhance the ability of MIPS eligible clinicians 
and groups to perform well in the program. Several commenters noted 
that taking a slower approach to increasing the data completeness 
criteria is the best way to ensure reliable and accurate data is 
submitted so that CMS has a complete and accurate reflection of MIPS 
eligible clinician performance.
    Response: While we understand the commenters' desire to take a more 
gradual approach, we must balance this with need to ensure that we have 
a complete an accurate reflection of MIPS eligible clinician 
performance. As such, we are not finalizing our proposal to decrease 
the data completeness threshold to 50 percent for the 2020 MIPS payment 
year and are instead retaining the previously finalized data 
completeness threshold of 60 percent for that year. In addition, we are 
finalizing our proposal to increase the data completeness threshold to 
60 percent for MIPS payment year 2021.
    Comment: A few commenters did not support our proposal to delay 
moving to a higher data completeness threshold until the 2019 MIPS 
performance period and 2021 MIPS payment year, expressing concern that 
a delay would encourage MIPS eligible clinicians and groups to avoid 
the selection of population-based measures that would more easily meet 
any higher completeness requirements that we might set; would 
negatively impact the ability of high performers to receive a 
substantial payment increase in the 2020 MIPS payment year; and would 
not prepare MIPS eligible clinicians and groups for a more rigorous 
program in future years. A few commenters suggested that 50 percent of 
available data is insufficient and that a larger patient sample 
provides a more reliable and valid representation of true performance 
and will better support clinician groups in internal benchmarking for 
quality improvement. One commenter noted that a delay would continue to 
create a misalignment between the MIPS and Advanced APM tracks. One 
commenter disagreed with the 50 percent threshold itself, expressing 
concern that this standard may motivate MIPS eligible clinicians and 
groups to ``cherry pick'' the cases that make up the denominator for 
reporting. This commenter suggested that for any reporting mechanism 
for which a MIPS eligible clinician could attest to a formal, auditable 
representative sampling, we should exempt the MIPS eligible clinician 
from the data completeness standard.
    Response: We agree that a larger sample reduces the likelihood of 
selection bias and provides a more reliable and valid representation of 
true performance. As a result, we are not finalizing our proposal to 
decrease the data completeness threshold to 50 percent for the 2020 
MIPS payment year and are instead retaining the previously finalized 
data completeness threshold of 60 percent for that year. In addition, 
we are finalizing our proposal to increase the data completeness 
threshold to 60 percent for MIPS payment year 2021.
    Final Action: After consideration of the public comments, we are 
not finalizing our proposal regarding the data completeness criteria 
for MIPS payment year 2020. Instead, we are retaining our previously 
finalized requirements at:
     Sec.  414.1340(a)(2) that MIPS eligible clinicians and 
groups submitting quality measures data using the QCDR, qualified 
registry, or EHR submission mechanism must submit data on at least 60 
percent of the MIPS eligible clinician or group's patients that meet 
the measure's denominator criteria, regardless of payer for MIPS 
payment year 2020; and
     Sec.  414.1340(b)(2) that MIPS eligible clinicians 
submitting quality measures data using Medicare Part B claims, must 
submit data on at least 60 percent of the applicable Medicare Part B 
patients seen during the performance period to which the measure 
applies for MIPS payment years 2020.
    We are, however, finalizing our proposal regarding the data 
completeness criteria for MIPS payment year 2021. Specifically, we are 
finalizing at:
     Sec.  414.1340(a)(2) that MIPS eligible clinicians and 
groups submitting quality measures data using the QCDR, qualified 
registry, or EHR submission mechanism must submit data on at least 60 
percent of the MIPS eligible clinician or group's patients that meet 
the measure's denominator criteria,

[[Page 53634]]

regardless of payer for MIPS payment year 2021; and
     Sec.  414.1340(b)(2) that MIPS eligible clinicians 
submitting quality measures data using Medicare Part B claims, must 
submit data on at least 60 percent of the applicable Medicare Part B 
patients seen during the performance period to which the measure 
applies for MIPS payment years 2021.
(c) Summary of Data Submission Criteria
    Table 5 reflects our final quality data submission criteria for 
MIPS payment years 2020 and 2021 via Medicare Part B claims, QCDR, 
qualified registry, EHR, CMS Web Interface, and the CAHPS for MIPS 
survey. It is important to note that while we finalized at Sec.  
414.1325(d) in the CY 2017 Quality Payment Program final rule that 
individual MIPS eligible clinicians and groups may only use one 
submission mechanism per performance category, in section II.C.6.a.(1) 
of this final rule with comment period, we are finalizing to revise 
Sec.  414.1325(d) for purposes of the 2021 MIPS payment year and future 
years to allow individual MIPS eligible clinicians and groups to submit 
measures and activities, as applicable, via as many submission 
mechanisms as necessary to meet the requirements of the quality, 
improvement activities, or advancing care information performance 
categories. We refer readers to section II.C.6.a.(1) of this final rule 
with comment period for further discussion of this policy.

    TABLE 5--Summary of Final Quality Data Submission Criteria for MIPS Payment Year 2020 and 2021 via Part B
             Claims, QCDR, Qualified Registry, EHR, CMS Web Interface, and the CAHPS for MIPS Survey
----------------------------------------------------------------------------------------------------------------
                                                   Submission
   Performance period       Clinician type         mechanism          Submission criteria     Data completeness
----------------------------------------------------------------------------------------------------------------
Jan 1-Dec 31...........  Individual MIPS      Part B Claims......  Report at least six       60 percent of
                          eligible                                  measures including one    individual MIPS
                          clinicians.                               outcome measure, or if    eligible
                                                                    an outcome measure is     clinician's
                                                                    not available report      Medicare Part B
                                                                    another high priority     patients for the
                                                                    measure; if less than     performance
                                                                    six measures apply then   period.
                                                                    report on each measure
                                                                    that is applicable.
                                                                    Individual MIPS
                                                                    eligible clinicians
                                                                    would have to select
                                                                    their measures from
                                                                    either the set of all
                                                                    MIPS measures listed or
                                                                    referenced, or one of
                                                                    the specialty measure
                                                                    sets listed in, the
                                                                    applicable final rule.
Jan 1-Dec 31...........  Individual MIPS      QCDR, Qualified      Report at least six       60 percent of
                          eligible             Registry, & EHR.     measures including one    individual MIPS
                          clinicians, groups.                       outcome measure, or if    eligible
                                                                    an outcome measure is     clinician's, or
                                                                    not available report      group's patients
                                                                    another high priority     across all payers
                                                                    measure; if less than     for the
                                                                    six measures apply then   performance
                                                                    report on each measure    period.
                                                                    that is applicable.
                                                                    Individual MIPS
                                                                    eligible clinicians, or
                                                                    groups would have to
                                                                    select their measures
                                                                    from either the set of
                                                                    all MIPS measures
                                                                    listed or referenced,
                                                                    or one of the specialty
                                                                    measure sets listed in,
                                                                    the applicable final
                                                                    rule.
Jan 1-Dec 31...........  Groups.............  CMS Web Interface..  Report on all measures    Sampling
                                                                    included in the CMS Web   requirements for
                                                                    Interface; AND populate   the group's
                                                                    data fields for the       Medicare Part B
                                                                    first 248 consecutively   patients.
                                                                    ranked and assigned
                                                                    Medicare beneficiaries
                                                                    in the order in which
                                                                    they appear in the
                                                                    group's sample for each
                                                                    module/measure. If the
                                                                    pool of eligible
                                                                    assigned beneficiaries
                                                                    is less than 248, then
                                                                    the group would report
                                                                    on 100 percent of
                                                                    assigned beneficiaries.
Jan 1-Dec 31...........  Groups.............  CAHPS for MIPS       CMS-approved survey       Sampling
                                               Survey.              vendor would need to be   requirements for
                                                                    paired with another       the group's
                                                                    reporting mechanism to    Medicare Part B
                                                                    ensure the minimum        patients.
                                                                    number of measures is
                                                                    reported. CAHPS for
                                                                    MIPS survey would
                                                                    fulfill the requirement
                                                                    for one patient
                                                                    experience measure
                                                                    towards the MIPS
                                                                    quality data submission
                                                                    criteria. CAHPS for
                                                                    MIPS survey would only
                                                                    count for one measure
                                                                    under the quality
                                                                    performance category.
----------------------------------------------------------------------------------------------------------------

    We note that the measure reporting requirements applicable to 
groups are also generally applicable to virtual groups. However, we 
note that the requirements for calculating measures and activities when 
reporting via QCDRs, qualified registries, EHRs, and attestation differ 
in their application to virtual groups. Specifically, these 
requirements apply cumulatively across all TINs in a virtual group. 
Thus, virtual groups will aggregate data for each NPI under each TIN 
within the virtual group by adding together the numerators and 
denominators and then cumulatively collate to report one measure ratio 
at the virtual group level. Moreover, if each MIPS eligible clinician 
within a virtual group faces a significant hardship or has EHR 
technology that has been decertified, the virtual group can apply for 
an exception to have its advancing care information performance 
category reweighted. If such exception application is approved, the 
virtual group's advancing care information performance category is 
reweighted to zero percent and applied to the quality performance 
category increasing the quality performance weight from 50 percent to 
75 percent.
    Additionally, the data submission criteria applicable to groups are 
also generally applicable to virtual groups. However, we note that data 
completeness and sampling requirements for the CMS Web Interface and 
CAHPS for MIPS survey differ in their application to virtual groups. 
Specifically, data completeness for virtual groups applies cumulatively 
across all TINs in a virtual group. Thus, we note that there may be a 
case when a virtual group has one TIN that falls below the 60 percent 
data completeness threshold, which is an acceptable case as long as the 
virtual group cumulatively exceeds such threshold. In regard to the CMS 
Web Interface and CAHPS for MIPS survey, sampling requirements pertain 
to Medicare Part B patients with respect to all TINs in a virtual 
group, where the sampling methodology would be conducted for

[[Page 53635]]

each TIN within the virtual group and then cumulatively aggregated 
across the virtual group. A virtual group would need to meet the 
beneficiary sampling threshold cumulatively as a virtual group.
(4) Application of Quality Measures to Non-Patient Facing MIPS Eligible 
Clinicians
    In the CY 2017 Quality Payment Program final rule (81 FR 77127), we 
finalized at Sec.  414.1335 that non-patient facing MIPS eligible 
clinicians would be required to meet the applicable submission criteria 
that apply for all MIPS eligible clinicians for the quality performance 
category. We did not propose any changes to this policy in the proposed 
rule.
(5) Application of Facility-Based Measures
    Section 1848(q)(2)(C)(ii) of the Act provides that the Secretary 
may use measures used for payment systems other than for physicians, 
such as measures used for inpatient hospitals, for purposes of the 
quality and cost performance categories. However, the Secretary may not 
use measures for hospital outpatient departments, except in the case of 
items and services furnished by emergency physicians, radiologists, and 
anesthesiologists. We refer readers to section II.C.7.a.(4) of this 
final rule with comment period for a full discussion of the finalized 
policies regarding the application of facility-based measures.
(6) Global and Population-Based Measures
    In the CY 2017 Quality Payment Program final rule (81 FR 77136), we 
did not finalize all of our proposals on global and population-based 
measures as part of the quality score. Specifically, we did not 
finalize our proposal to use the acute and chronic composite measures 
of the AHRQ Prevention Quality Indicators (PQIs). We agreed with 
commenters that additional enhancements, including the addition of risk 
adjustment, needed to be made to these measures prior to inclusion in 
MIPS. We did, however, calculate these measures at the TIN level, and 
provided the measure data through the QRURs released in September 2016, 
and this data can be used by MIPS eligible clinicians for informational 
purposes.
    We did finalize the all-cause hospital readmissions (ACR) measure 
from the VM Program as part of the annual list of quality measures for 
the MIPS quality performance category. We finalized this measure with 
the following modifications. We did not apply the ACR measure to solo 
practices or small groups (groups of 15 or less). We did apply the ACR 
measure to groups of 16 or more who meet the case volume of 200 cases. 
A group will be scored on the ACR measure even if it did not submit any 
quality measures, if it submitted in other performance categories. 
Otherwise, the group will not be scored on the readmission measure if 
it did not submit data in any of the performance categories. In our 
transition year policies, the readmission measure alone would not 
produce a neutral to positive MIPS payment adjustment since in order to 
achieve a neutral to positive MIPS payment adjustment, an individual 
MIPS eligible clinician or group must submit information in one of the 
three performance categories as discussed in the CY 2017 Quality 
Payment Program final rule (81 FR 77329). However, for MIPS eligible 
clinicians who did not meet the minimum case requirements, the ACR 
measure was not applicable. In the CY 2018 Quality Payment Program 
proposed rule, we did not propose to remove this measure from the list 
of quality measures for the MIPS quality performance category. Nor did 
we propose any changes for the ACR measure in the proposed rule. As 
discussed in section II.C.4.d. of this final rule with comment period, 
we are finalizing our proposal to generally apply our finalized group 
policies to virtual groups.
c. Selection of MIPS Quality Measures for Individual MIPS Eligible 
Clinicians and Groups Under the Annual List of Quality Measures 
Available for MIPS Assessment
(1) Background and Policies for the Call for Measures and Measure 
Selection Process
    Under section 1848(q)(2)(D)(i) of the Act, the Secretary, through 
notice and comment rulemaking, must establish an annual list of MIPS 
quality measures from which MIPS eligible clinicians may choose for 
purposes of assessment for a performance period. The annual list of 
MIPS quality measures must be published in the Federal Register no 
later than November 1 of the year prior to the first day of a 
performance period. Updates to the annual list of MIPS quality measures 
must be published in the Federal Register no later than November 1 of 
the year prior to the first day of each subsequent performance period. 
Updates may include the addition of new MIPS quality measures, 
substantive changes to MIPS quality measures, and removal of MIPS 
quality measures. We refer readers to the CY 2018 Quality Payment 
Program proposed rule (82 FR 30043 and 30044) for additional 
information regarding eCQM reporting and the Measure Development Plan 
that serves as a strategic framework for the future of the clinician 
quality measure development to support MIPS and APMs. We encourage 
stakeholders to develop additional quality measures for MIPS that would 
address the gaps.
    Under section 1848(q)(2)(D)(ii) of the Act, the Secretary must 
solicit a ``Call for Quality Measures Under Consideration'' each year. 
Specifically, the Secretary must request that eligible clinician 
organizations and other relevant stakeholders identify and submit 
quality measures to be considered for selection in the annual list of 
MIPS quality measures, as well as updates to the measures. Under 
section 1848(q)(2)(D)(ii) of the Act, eligible clinician organizations 
are professional organizations as defined by nationally recognized 
specialty boards of certification or equivalent certification boards. 
However, we do not believe there needs to be any special restrictions 
on the type or make-up of the organizations that submit measures for 
consideration through the call for measures. Any such restriction would 
limit the type of quality measures and the scope and utility of the 
quality measures that may be considered for inclusion under the MIPS.
    As we described previously in the CY 2017 Quality Payment Program 
final rule (81 FR 77137), we will accept quality measures submissions 
at any time, but only measures submitted during the timeframe provided 
by us through the pre-rulemaking process of each year will be 
considered for inclusion in the annual list of MIPS quality measures 
for the performance period beginning 2 years after the measure is 
submitted. This process is consistent with the pre-rulemaking process 
and the annual call for measures, which are further described at 
(https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityMeasures/Pre-Rule-Making.html).
    Submission of potential quality measures, regardless of whether 
they were previously published in a proposed rule or endorsed by an 
entity with a contract under section 1890(a) of the Act, which is 
currently the National Quality Forum, is encouraged. The annual Call 
for Measures process allows eligible clinician organizations and other 
relevant stakeholder organizations to identify and submit quality 
measures for consideration. Presumably, stakeholders would not submit

[[Page 53636]]

measures for consideration unless they believe that the measure is 
applicable to clinicians and can be reliably and validly measured at 
the individual clinician level. The NQF-convened Measure Application 
Partnership (MAP) provides an additional opportunity for stakeholders 
to provide input on whether or not they believe the measures are 
applicable to clinicians as well as feasible, scientifically 
acceptable, and reliable and valid at the clinician level. Furthermore, 
we must go through notice and comment rulemaking to establish the 
annual list of quality measures, which gives stakeholders an additional 
opportunity to review the measures and provide input on whether or not 
they believe the measures are applicable to clinicians, as well as 
feasible, scientifically acceptable, and reliable and valid at the 
clinician level. Additionally, we are required by statute to submit new 
measures to an applicable specialty- appropriate, peer-reviewed 
journal.
    As previously noted, we encourage the submission of potential 
quality measures regardless of whether such measures were previously 
published in a proposed rule or endorsed by an entity with a contract 
under section 1890(a) of the Act. However, we proposed to request that 
stakeholders apply the following considerations when submitting quality 
measures for possible inclusion in MIPS:
     Measures that are not duplicative of an existing or 
proposed measure.
     Measures that are beyond the measure concept phase of 
development and have started testing, at a minimum, with strong 
encouragement and preference for measures that have completed or are 
near completion of reliability and validity testing.
     Measures that include a data submission method beyond 
claims-based data submission.
     Measures that are outcome-based rather than clinical 
process measures.
     Measures that address patient safety and adverse events.
     Measures that identify appropriate use of diagnosis and 
therapeutics.
     Measures that address the domain for care coordination.
     Measures that address the domain for patient and caregiver 
experience.
     Measures that address efficiency, cost, and resource use.
     Measures that address significant variation in 
performance.
    We will apply these considerations when considering quality 
measures for possible inclusion in MIPS.
    In addition, we note that we are likely to reject measures that do 
not provide substantial evidence of variation in performance; for 
example, if a measure developer submits data showing a small variation 
in performance among a group already composed of high performers, such 
evidence would not be substantial enough to assure us that sufficient 
variation in performance exists. We also noted that we are likely to 
reject measures that are not outcome-based measures, unless: (1) There 
is substantial documented and peer reviewed evidence that the clinical 
process measured varies directly with the outcome of interest; and (2) 
it is not possible to measure the outcome of interest in a reasonable 
timeframe.
    We also noted that retired measures that were in one of CMS's 
previous quality programs, such as the Physician Quality Reporting 
System (PQRS) program, will likely be rejected if proposed for 
inclusion. This includes measures that were retired due to being topped 
out, as defined below. For example, measures may be retired due to 
attaining topped out status because of high performance, or measures 
that are retired due to a change in the evidence supporting their use.
    In the CY 2017 Quality Payment Program final rule (81 FR 77153), we 
established that we will categorize measures into the six NQS domains 
(patient safety, person- and caregiver-centered experience and 
outcomes, communication and care coordination, effective clinical care, 
community/population health, and efficiency and cost reduction). We 
intend to submit future MIPS quality measures to the NQF-convened 
Measure Application Partnership's (MAP), as appropriate, and we intend 
to consider the MAP's recommendations as part of the comprehensive 
assessment of each measure considered for inclusion under MIPS.
    In the CY 2017 Quality Payment Program final rule (81 FR 77155), we 
established that we use the Call for Quality Measures process as a 
forum to gather the information necessary to draft the journal articles 
for submission from measure developers, measure owners and measure 
stewards. The submission of this information does not preclude us from 
conducting our own research using Medicare claims data, Medicare survey 
results, and other data sources that we possess. We submit new measures 
for publication in applicable specialty-appropriate, peer-reviewed 
journals before including such measures in the final annual list of 
quality measures.
    In the CY 2017 Quality Payment Program final rule (81 FR 77158), we 
established at Sec.  414.1330(a)(2) that for purposes of assessing 
performance of MIPS eligible clinicians in the quality performance 
category, we use quality measures developed by QCDRs. In the 
circumstances where a QCDR wants to use a QCDR measure for inclusion in 
the MIPS program for reporting, those measures go through a CMS 
approval process during the QCDR self-nomination period. We also 
established that we post the quality measures for use by QCDRs by no 
later than January 1 for performance periods occurring in 2018 and 
future years.
    Previously finalized MIPS quality measures can be found in the CY 
2017 Quality Payment Program final rule (81 FR 77558 through 77675). 
Updates may include the addition of proposed new MIPS quality measures, 
including measures selected 2 years ago during the Call for Measures 
process. The new MIPS quality measures proposed for inclusion in MIPS 
for the 2018 performance period and future years were found in Table A 
of the CY 2018 Quality Payment Program proposed rule (82 FR 30261 
through 30270). The proposed new and modified MIPS specialty sets for 
the 2018 performance period and future years were listed in Table B of 
the CY 2018 Quality Payment Program proposed rule (82 FR 30271 through 
30454), and included existing measures that were proposed with 
modifications, new measures, and measures finalized in the CY 2017 
Quality Payment Program final rule. We noted that the modifications 
made to the specialty sets may include the removal of certain quality 
measures that were previously finalized. The specialty measure sets 
should be used as a guide for eligible clinicians to choose measures 
applicable to their specialty. To clarify, some of the MIPS specialty 
sets have further defined subspecialty sets, each of which is 
effectively a separate specialty set. In instances where an individual 
MIPS eligible clinician or group reports on a specialty or subspecialty 
set, if the set has less than six measures, that is all the clinician 
is required to report. MIPS eligible clinicians are not required to 
report on the specialty measure sets, but they are suggested measures 
for specific specialties. Throughout measure utilization, measure 
maintenance should be a continuous process done by the measure owners, 
to include environmental scans of scientific literature about the 
measure. New information gathered during this ongoing review may 
trigger an ad hoc review. Please note that these specialty specific 
measure sets are not all inclusive of every specialty or subspecialty. 
On January 25, 2017, we announced that we would be accepting

[[Page 53637]]

recommendations for potential new specialty measure sets for year 2 of 
MIPS under the Quality Payment Program. These recommendations were 
based on the MIPS quality measures finalized in the CY 2017 Quality 
Payment Program final rule, and include recommendations to add or 
remove the current MIPS quality measures from the specialty measure 
sets. The current specialty measure sets can be found on the Quality 
Payment Program Web site at https://qpp.cms.gov/measures/quality. All 
specialty measure sets submitted for consideration were assessed to 
ensure that they met the needs of the Quality Payment Program.
    As a result, we proposed (82 FR 30045) to add new quality measures 
to MIPS (Table A in the proposed rule (82 FR 30261 through 30270)), 
revise the specialty measure sets in MIPS (Table B in the proposed rule 
(82 FR 30271 through 30454)), remove specific MIPS quality measures 
only from specialty sets (Table C.1 in the proposed rule (82 FR 30455 
through 30462)), and proposed to remove specific MIPS quality measures 
from the MIPS program for the 2018 performance period (Table C.2 in the 
proposed rule (82 FR 30463 through 30465)). In addition, we proposed to 
also remove cross cutting measures from most of the specialty sets. 
Specialty groups and societies reported that cross cutting measures may 
or may not be relevant to their practices, contingent on the eligible 
clinicians or groups. We chose to retain the cross cutting measures in 
Family Practice, Internal Medicine, and Pediatrics specialty sets 
because they are frequently used in these practices. The proposed 2017 
cross cutting measures (81 FR 28447 through 28449) were compiled and 
placed in a separate table for eligible clinicians to elect to use or 
not, for reporting. To clarify, the cross-cutting measures are intended 
to provide clinicians with a list of measures that are broadly 
applicable to all clinicians regardless of the clinician's specialty. 
Even though it is not required to report on cross-cutting measures, it 
is provided as a reference to clinicians who are looking for additional 
measures to report outside their specialty. We continue to consider 
cross-cutting measures to be an important part of our quality measure 
programs, and seek comment on ways to incorporate cross-cutting 
measures into MIPS in the future. The Table of Cross-Cutting Measures 
can be found in Table D of the Appendix in the CY 2018 Quality Payment 
Program proposed rule (82 FR 30466 through 30467).
    For MIPS quality measures that are undergoing substantive changes, 
we proposed to identify measures including, but not limited to measures 
that have had measure specification, measure title, and domain changes. 
MIPS quality measures with proposed substantive changes can be found at 
Table E of the Appendix in the CY 2018 Quality Payment Program proposed 
rule (82 FR 30468 through 30478).
    The measures that would be used for the APM scoring standard and 
our authority for waiving certain measure requirements are described in 
section II.C.6.g.(3)(b)(ii) of this final rule with comment period, and 
the measures that would be used to calculate a quality score for the 
APM scoring standard are proposed in Tables 14, 15, and 16 of the CY 
2018 Quality Payment Program proposed rule (82 FR 30091 through 30095).
    We also sought comment on whether there are any MIPS quality 
measures that commenters believe should be classified in a different 
NQS domain than what is being proposed, or that should be classified as 
a different measure type (for example, process vs. outcome) than what 
we proposed (82 FR 30045). We did not receive any public comments in 
response to this solicitation.
    The following is a summary of the public comments received on the 
``Background and Policies for the Call for Measures and Measure 
Selection Process proposals and our responses:
    Comment: A few commenters supported the proposal to remove cross-
cutting measures from most specialty sets. One commenter agreed that 
cross-cutting measures may or may not be relevant to certain practices.
    Response: We appreciate the commenters support.
    Comment: One commenter recommended that CMS retain cross-cutting 
measures in specialty sets with fewer than six measures because the 
commenter believed it would allow parity in quality measure reporting 
across all clinicians and provide incentives for all specialties to 
develop quality measures.
    Response: We did not retain the cross-cutting measures in all the 
specialty sets, including those sets with less than six measures, 
because we believe that cross-cutting measures are not necessarily 
reflective of all specialty groups' scope of their practice. One goal 
of the MIPS program is to ensure that meaningful measurement occurs, 
and CMS chose to retain the cross cutting measures in Family Practice, 
Internal Medicine, and Pediatrics specialty sets because they are 
frequently used in these practices. The cross-cutting measures are 
intended to provide clinicians with a list of measures that are broadly 
applicable to all clinicians regardless of the clinician's specialty. 
Even though MIPS eligible clinicians are not required to report on 
cross-cutting measures, they are provided as a reference to clinicians 
who are looking for additional measures to report outside their 
specialty.
    Final Action: After consideration of the public comments received, 
we refer readers to the appendix of this final rule with comment period 
for the finalized list of new quality measures available for reporting 
in MIPS for the 2018 performance period and future years (Table A); the 
finalized specialty measure sets available for reporting in MIPS for 
the 2018 performance period and future years (Table B); the MIPS 
quality measures removed only from specialty sets for the 2018 
performance period and future years (Table C.1); the MIPS quality 
measures removed from the MIPS program for the 2018 performance period 
and future years (Table C.2); the cross-cutting measures available for 
the 2018 MIPS performance period and future years (Table D); and the 
MIPS quality measures finalized with substantive changes for the 2018 
performance period and future years (Table E).
(2) Topped Out Measures
    As defined in the CY 2017 Quality Payment Program final rule at (81 
FR 77136), a measure may be considered topped out if measure 
performance is so high and unvarying that meaningful distinctions and 
improvement in performance can no longer be made. Topped out measures 
could have a disproportionate impact on the scores for certain MIPS 
eligible clinicians, and provide little room for improvement for the 
majority of MIPS eligible clinicians. We refer readers to section 
II.C.7.a.(2)(c) of this final rule with comment period for additional 
information regarding the scoring of topped out measures.
    Although we proposed a 3-year timeline to identify and propose to 
remove (through future rulemaking) topped out measures (82 FR 30046). 
We would like to clarify that the proposed timeline is more accurately 
described as a 4-year timeline. After a measure has been identified as 
topped out for 3 consecutive years, we may propose to remove the 
measure through notice-and-comment rulemaking for the 4th year. 
Therefore, in the 4th year, if finalized through rulemaking, the 
measure would be removed and would no longer be available for reporting 
during the performance period. This proposal would provide a path 
toward removing topped out measures over time, and will

[[Page 53638]]

apply to the MIPS quality measures. QCDR measures that consistently are 
identified as topped out according to the same timeline as proposed 
below, would not be approved for use in year 4 during the QCDR self-
nomination review process. These identified QCDR measures would not be 
removed through the notice-and-comment and rulemaking process described 
below.
    We proposed to phase in this policy starting with a select set of 
six highly topped out measures identified in section II.C.7.a.(2)(c) of 
this final rule with comment period. We also proposed to phase in 
special scoring for measures identified as topped out in the published 
benchmarks for 2 consecutive performance periods, starting with the 
select set of highly topped out measures for the 2018 MIPS performance 
period. An example illustrating the proposed timeline for the removal 
and special scoring of topped out measures, as it would be applied to 
the select set of highly topped out measures identified in section 
II.C.7.a.(2)(c) of this final rule with comment period, is as follows:
     Year 1: Measures are identified as topped out in the 
benchmarks published for the 2017 MIPS performance Period. The 2017 
benchmarks are posted on the Quality Payment Program Web site: https://qpp.cms.gov/resources/education.
     Year 2: Measures are identified as topped out in the 
benchmarks published for the 2018 MIPS performance period. We refer 
readers to section II.C.7.a.(2)(c) of this final rule with comment 
period for additional information regarding the scoring of topped out 
measures.
     Year 3: Measures are identified as topped out in the 
benchmarks published for the 2019 MIPS performance period. The measures 
identified as topped out in the benchmarks published for the 2019 MIPS 
performance period and the previous two consecutive performance periods 
would continue to have special scoring applied for the 2019 MIPS 
performance period and would be considered, through notice-and-comment 
rulemaking, for removal for the 2020 MIPS performance period.
     Year 4: Topped out measures that are finalized for removal 
are no longer available for reporting. For example, the measures in the 
set of highly topped out measures identified as topped out for the 
2017, 2018 and 2019 MIPS performance periods, and if subsequently 
finalized for removal will not be available on the list of measures for 
the 2020 MIPS performance period and future years.
    For all other measures, the timeline would apply starting with the 
benchmarks for the 2018 MIPS performance period. Thus, the first year 
any other topped out measure could be proposed for removal would be in 
rulemaking for the 2021 MIPS performance period, based on the 
benchmarks being topped out in the 2018, 2019, and 2020 MIPS 
performance periods. If the measure benchmark is not topped out during 
one of the 3 MIPS performance periods, then the lifecycle would stop 
and start again at year 1 the next time the measure benchmark is topped 
out.
    We sought comment on the proposed timeline; specifically, regarding 
the number of years before a topped out measure is identified and 
considered for removal, and under what circumstances we should remove 
topped out measures once they reach that point (82 FR 30046). We also 
noted that if for some reason a measure benchmark is topped out for 
only one submission mechanism benchmark, then we would remove that 
measure from the submission mechanism, but not remove the measure from 
other submission mechanisms available for submitting that measure. The 
comments we received and our responses are discussed further below.
    We also sought comment on whether topped out Summary Survey 
Measures (SSMs), if topped out, should be considered for removal from 
the Consumer Assessment of Healthcare Providers and Systems (CAHPS) for 
MIPS Clinician or Group Survey measure due to high, unvarying 
performance within the SSM, or whether there is another alternative 
policy that could be applied for topped out SSMs within the CAHPS for 
MIPS Clinician or Group Survey measure (82 FR 30046). We received a 
comment on this item and appreciate the input received. As this was a 
request for comment only, we will take the feedback provided into 
consideration for future rulemaking.
    In the CY 2017 Quality Payment Program final rule, we stated that 
we do not believe it would be appropriate to remove topped out measures 
from the CMS Web Interface for the Quality Payment Program because the 
CMS Web Interface measures are used in MIPS and in APMs, such as the 
Shared Savings Program. Removing topped out measures from the CMS Web 
Interface would not be appropriate because we have aligned policies 
where possible, with the Shared Savings Program, such as using the 
Shared Savings Program benchmarks for the CMS Web Interface measures 
(81 FR 77285). In the CY 2017 Quality Payment Program final rule, we 
also finalized that MIPS eligible clinicians reporting via the CMS Web 
Interface must report all measures included in the CMS Web Interface 
(81 FR 77116). Thus, if a CMS Web Interface measure is topped out, the 
CMS Web Interface reporter cannot select other measures. We refer 
readers to section II.C.7.a.(2) of this final rule with comment period 
for information on scoring policies with regards to topped out measures 
from the CMS Web Interface for the Quality Payment Program. We did not 
propose to include CMS Web Interface measures in our proposal on 
removing topped out measures.
    The following is a summary of the public comments received on the 
``Topped Out Measures'' proposals and our responses:
    Comment: Many commenters supported the proposed timeline for 
identification and removal of topped out measures because the process 
relies on multiple years of data and the lifecycle permits enough time 
to avoid disadvantaging certain clinicians who may report these 
measures. The commenters supported the lifecycle over multiple years to 
find a trend in high performance, providing time for consideration of 
replacement measures to sustain the focus on clinical areas where 
improvement opportunities exist. A few commenters supported the 
timeline and encouraged CMS to develop a more comprehensive approach to 
identifying topped out measures, to ensure that voluntary reporting on 
a menu of quality measures does not allow eligible clinicians to 
`cherry pick' measures. One commenter supported not applying the topped 
out measure policies to measures in the CMS Web Interface to align with 
measures used in APMs such as the Shared Savings Program for the CMS 
Web Interface submission mechanism for the Quality Payment Program.
    Response: We agree that by identifying and removing topped out 
measures, we may greatly reduce eligible clinicians' ability to 
``cherry pick'' measures. We believe that the benchmarks will help us 
identify those measures that meet our definition of topped out 
measures.
    Comment: Many commenters did not support removal of the measures, 
because they noted: Benchmarks published for the 2017 performance 
period were not derived from MIPS reported data; criteria to identify 
topped out measures did not include consideration of important clinical 
considerations including patient safety and the ability to accurately 
measure and motivate high quality care; and removal of measures may 
disproportionately impact one submission mechanism or clinicians

[[Page 53639]]

based on medical specialty, practice size or regional variation. 
Several commenters indicated that identification of topped out measures 
is challenging because measures are voluntarily selected with limited 
reporting on each measure, and thus benchmarks may appear to be topped 
out when in fact there is still the room for improvement. A few 
commenters cautioned against removing measures because this may lead to 
``back sliding'' due to a shift in resources from support of current 
practices yielding high performance to new practices to support a new 
measure. Several commenters indicated that the criteria for selection 
of topped out measures should be expanded to consider the clinical 
importance of measures, and a few commenters recommended the 
identification of measures that are essential for high quality care 
such as patient safety, public health or patient experience that should 
never be removed from the list of measures. Many commenters voiced 
concern over the potential number of measures that may be topped out 
which they believed would leave eligible clinicians, particularly 
specialists with few relevant measures to submit. Many commenters 
recommended only removing topped out measures if there are adequate 
replacement measures added to the measures list. A few commenters 
indicated that topped out measures could be incorporated into composite 
measures reflecting multiple, important aspects of care. A few 
commenters recommended that prior to the removal of a measure, CMS 
evaluate the topped out measure across submission mechanisms to 
determine if the measure is harmonized across submission mechanisms.
    Response: The benchmarks for the 2017 performance period are 
derived from the measure's historical performance data which helps us 
trend the measure's anticipated performance in the future. Topped out 
measures are considered topped out if the measure performance is so 
high and unvarying that meaningful differences and improvement in 
performance can no longer be seen. Retaining topped out measures could 
have a disproportionate impact on the scores for certain MIPS eligible 
clinicians. We note that topped out measures must be consecutively 
identified for 3 years (in MIPS) as topped out before it is proposed 
for removal in the 4th year through rulemaking and comment period. As a 
part of the topped out measure timeline, we will take into 
consideration other factors such as clinical relevance and the 
availability of other relevant specialty measures prior to deciding 
whether or not to remove the measure from the program. Through the Call 
for Measures process and annual approval of QCDR measures, we 
anticipate that MIPS eligible clinicians and groups will have measures 
that provide meaningful measurement and are reflective of their current 
scope of practice. We believe that through the annual Call for Measures 
and QCDR self-nomination processes additional quality measures will be 
developed and implemented in the program, that will provide eligible 
clinicians and groups with a continuously growing selection of measures 
to choose from that will allow for meaningful measurement. We recognize 
that there are certain types of high value measures such as patient 
safety and patient experience, but we disagree that such measures 
should be designated as never to be removed from the list of available 
quality measures. We thank the commenters for their suggestion to 
remove topped out measures if there are adequate replacement measures 
added to the measures list, and we will take this into consideration, 
while encouraging measure stewards to submit measures to us through the 
Call for Measures process. We would like to note that this policy 
creates a standard timeline for us to consider which measures are 
topped out and may need to be removed. Each removal would need to be 
proposed and finalized through rulemaking, and we would have the 
discretion to retain any particular measure that, after consideration 
of public comments and other factors, may be determined to be 
inappropriate for removal.
    Comment: Several commenters did not support the removal of topped 
out measures from QCDR submissions because commenters believed this 
would reduce the ability of specialists to develop and strengthen new 
measures. A few commenters believed that not including QCDR measures in 
the topped out measure policy would ensure that eligible clinicians, 
including anesthesia clinicians, have measures of merit during the 
transition to full implementation of MIPS. One commenter urged CMS not 
to remove QCDR topped out measures but rather allow topped out measures 
as controls for new and developing measures by which true statistical 
validity and reliability can be assessed. One commenter voiced concern 
over potential removal of QCDR topped out measures without going 
through the notice-and-comment rulemaking process. One commenter 
indicated that EHR measures used by QCDRs are less likely to be topped 
out because QCDRs led by specialty societies have significant expertise 
in quality measure development, measurement, and implementation, and 
are uniquely poised to develop and test meaningful measures. The 
commenter indicated that specialty registries can continue to monitor 
vital topped out measures, even if the measures are removed from MIPS 
reporting. A few commenters noted that many topped out process measures 
are important to monitor and to provide feedback to clinicians because 
less than very high performance is concerning and should be flagged.
    Response: We disagree that the removal of topped out QCDR measures 
would reduce the ability of specialists to develop and strengthen new 
measures. Rather, we believe that QCDRs can develop QCDR measures that 
would address areas in which there is a known performance gap and in 
which there is need for improvement. We also disagree that the removal 
of QCDR measures should occur through the notice-and-comment rulemaking 
process, as QCDR measures are not approved for use in the program 
through rulemaking. We refer readers to section 1848(q)(2)(D)(vi) of 
the Act, which expressly provides that QCDR measures are not subject to 
the notice-and-comment rulemaking requirements described in section 
1848(q)(2)(D)(i) of the Act that apply to other MIPS measures, and that 
the Secretary is only required to publish the list of QCDR measures on 
the CMS Web site. We appreciate the QCDRs expertise in given areas of 
specialty, but as previously indicated, we will utilize benchmarks for 
all submission mechanisms to appropriately identify measures as topped 
out, and will consider performance in all submission mechanisms before 
indicating that a given measure is topped out. QCDR measures should 
also be removed from MIPS through a similar timeline when QCDR measures 
meet the definition of a topped out measure. We understand the 
importance of monitoring high performance among clinicians, but we also 
believe that topped out QCDR measures may inadvertently penalize 
clinicians who are considered high performers when they are compared to 
other high performer clinicians, as described in the CY 2017 Quality 
Payment Program final rule (81 FR 77286). For example, a clinician who 
performs at the 90th percentile, when compared to another high 
performing clinician who scored in the 98th percentile, could 
potentially receive a lower score based on the cohort in

[[Page 53640]]

which they are compared. QCDR measures, their performance data, and 
clinical relevance are reviewed extensively as QCDRs self-nominate and 
submit their QCDR measures for consideration on an annual basis. We 
agree that specialty registries can continue to monitor their data 
submission of topped out measures for purposes of monitoring 
performance and improvement, even after the measures are removed from 
MIPS. Additional data provided by QCDRs or discussions about their QCDR 
measures is taken into consideration during the review process.
    Comment: A few commenters encouraged CMS to have a transparent 
process using multiple communication processes to indicate which 
measures are topped out and which measures will have the scoring cap to 
ensure MIPS eligible clinicians have the necessary time to alter their 
reporting under the quality performance category before topped-out 
measures are finalized for removal. Some commenters recommended that 
CMS provide detailed information on the measures considered to be 
topped-out, including the number and type of clinicians or groups 
reporting the measure each year, the number and type of clinicians or 
groups consistently reporting the measure, the range of performance 
scores and any statistical testing information. Other commenters 
suggested that CMS announce the status of a topped out measure in a 
draft proposed rule with at least a 45-day comment period. One 
commenter urged CMS to announce topped out measures at a consistent 
time each year.
    Response: We intend to indicate which measures are topped out 
through the benchmarks that will be published on the Quality Payment 
Program Web site annually, as feasible prior to the beginning of each 
performance period. We intend to consider, and as appropriate, propose 
removal of topped out measures in future notice-and-comment rulemaking 
in accordance with the proposed timeline. We thank commenters for their 
suggestions as to what information should be available on measures 
considered topped out and will provide additional data elements, as 
technically feasible and appropriate.
    Comment: A few commenters did not support the proposed lifecycle 
and made suggestions regarding the delay of the initiation of the 
lifecycle or extension to the timeline, to allow more time to adjust 
and continue to demonstrate improvement over time within MIPS. A few 
commenters recommended lengthening the lifecycle by 1 year, allowing 
the measure to be scored for 2 years after the measure is identified as 
topped out. The commenters indicated this will support MIPS eligible 
clinicians in incorporating appropriate measures into EHR systems and 
updating clinical practice. Several commenters recommended a delay in 
the start of the lifecycle to allow benchmarks to be developed from 
MIPS data and a more representative sample, while giving time for MIPS 
eligible clinicians to experience the program. One commenter requested 
a delay in the initiation of the lifecycle for measures without a 
benchmark to allow additional submissions in future years which may 
lead to the development of benchmarks.
    Response: We note that the topped out measure lifecycle has built 
in a 4-year timeline, which would be triggered when topped out measures 
are identified through the benchmarks as topped out. We believe the 4-
year timeline would provide MIPS eligible clinicians, groups, and 
third-party intermediaries with a sufficient amount of time to adjust 
to the removal of identified topped out measures. Topped out measures 
are identified through the benchmarks, and cannot be identified as 
topped out until the benchmark is established. We would like to note 
that this policy creates a standard timeline for us to consider which 
measures are topped out and may need to be removed. Each removal would 
need to be proposed and finalized through rulemaking, and we would have 
the discretion to retain any particular measure that, after 
consideration of public comments and other factors may be determined to 
be inappropriate for removal. We believe that the 4-year timeline will 
provide MIPS eligible clinicians with sufficient time to incorporate 
measures into their EHR systems and to update their clinical practice.
    Comment: A few commenters did not support the proposed topped out 
measure removal timeline, noting that the proposal would delay the 
retirement of topped out measures and selection and use of different 
quality measures. One commenter believed that allowing performance to 
be supported by the selection of topped out measures will not provide 
sufficient incentive for eligible clinicians to select the more 
challenging and difficult measures available.
    Response: We believe that the topped out measure timeline reflects 
a sufficient amount of time in which we are able to clearly distinguish 
topped out measures through their performance in the benchmarks. The 
timing will allow us to take into consideration any variances in the 
benchmarks, and provide sufficient timing to request public comment on 
the proposed removal of topped out measures. There are a variety of 
quality and QCDR measures to choose from in the MIPS program, and we 
encourage MIPS individual eligible clinicians and groups to select 
measures that provide meaningful measurement for them.
    Final Action: After consideration of the public comments received 
and since topped out measures may provide little room for improvement 
for the majority of MIPS eligible clinicians, and a disproportionate 
impact on the scores for certain MIPS eligible clinicians, we are 
finalizing our proposed 4-year timeline to identify topped out 
measures, after which we may propose to remove the measures through 
future rule making topped out measures. After a measure has been 
identified as topped out for 3 consecutive years, we may propose to 
remove the measure through notice and comment rulemaking for the 4th 
year. Therefore, in the 4th year, if finalized through rulemaking, the 
measure would be removed and would no longer be available for reporting 
during the performance period. This policy provides a path toward 
removing topped out MIPS quality measures over time. QCDR measures that 
consistently are identified as topped out according to the same 
timeline would not be approved for use in year 4 during the QCDR self-
nomination review process. Removal of these QCDR measures would not go 
through the comment and rulemaking process as MIPS quality measures 
would.
(3) Non-Outcome Measures
    In the CY 2017 Quality Payment Program final rule, we sought 
comment on whether we should remove non-outcomes measures for which 
performance cannot reliably be scored against a benchmark (for example, 
measures that do not have 20 reporters with 20 cases that meet the data 
completeness standard) for 3 years in a row (81 FR 77288).
    Based on the need for CMS to further assess this issue, we did not 
propose to remove non-outcome measures. However, we sought comment on 
what the best timeline for removing both non-outcome and outcome 
measures that cannot be reliably scored against a benchmark for 3 years 
(82 FR 30047). We received a number of comments on this item and 
appreciate the input received. As this was a request for comment only, 
we will take the feedback provided into consideration for future 
rulemaking.

[[Page 53641]]

(4) Quality Measures Determined To Be Outcome Measures
    Under the MIPS, individual MIPS eligible clinicians are generally 
required to submit at least one outcome measure, or, if no outcome 
measure is available, one high priority measure. As such, our 
determinations as to whether a measure is an outcome measure is of 
importance to stakeholders. We did not make any proposals on how 
quality measures are determined to be outcome measures, and refer 
readers to the CY 2018 Quality Payment Program proposed rule (82 FR 
30047) for the criteria utilized in determining if a measure is 
considered an outcome measure. We sought comment on the criteria and 
process outlined in the proposed rule on how we designate outcome 
measures (82 FR 30047). We received a number of comments on this item 
and appreciate the input received. As this was a request for comment 
only, we will take the feedback provided into consideration for future 
rulemaking.
d. Cost Performance Category
(1) Background
(a) General Overview
    Measuring cost is an integral part of measuring value as part of 
MIPS. In implementing the cost performance category for the transition 
year (2017 MIPS performance period/2019 MIPS payment year), we started 
with measures that had been used in previous programs (mainly the VM) 
but noted our intent to move towards episode-based measurement as soon 
as possible, consistent with the statute and the feedback from the 
clinician community. Specifically, we adopted 2 measures that had been 
used in the VM: The total per capita costs for all attributed 
beneficiaries measure (referred to as the total per capita cost 
measure); and the MSPB measure (81 FR 77166 through 77168). We also 
adopted 10 episode-based measures that had previously been included in 
the Supplemental Quality and Resource Use Reports (sQRURs) (81 FR 77171 
through 77174).
    At Sec.  414.1325(e), we finalized that all measures used under the 
cost performance category would be derived from Medicare administrative 
claims data and, thus, participation would not require additional data 
submission. We finalized a reliability threshold of 0.4 for measures in 
the cost performance category (81 FR 77170). We also finalized a case 
minimum of 35 for the MSPB measure (81 FR 77171) and 20 for the total 
per capita cost measure (81 FR 77170) and each of the 10 episode-based 
measures (81 FR 77175) in the cost performance category to ensure the 
reliability threshold is met.
    For the transition year, we finalized a policy to weight the cost 
performance category at zero percent of the final score in order to 
give clinicians more opportunity to understand the attribution and 
scoring methodologies and gain more familiarity with the measures 
through performance feedback so that clinicians may take action to 
improve their performance (81 FR 77165 through 77166). In the CY 2017 
Quality Payment Program final rule, we finalized a cost performance 
category weight of 10 percent for the 2020 MIPS payment year (81 FR 
77165). For the 2021 MIPS payment year and beyond, the cost performance 
category will have a weight of 30 percent of the final score as 
required by section 1848(q)(5)(E)(i)(II)(aa) of the Act.
    For descriptions of the statutory basis and our existing policies 
for the cost performance category, we refer readers to the CY 2017 
Quality Payment Program final rule (81 FR 77162 through 77177).
    As finalized at Sec.  414.1370(g)(2), the cost performance category 
is weighted at zero percent for MIPS eligible clinicians scored under 
the MIPS APM scoring standard because many MIPS APMs incorporate cost 
measurement in other ways. For more on the APM scoring standard, see 
II.C.6.g. of this final rule with comment period.
(2) Weighting in the Final Score
    We proposed at Sec.  414.1350(b)(2) to change the weight of the 
cost performance category from 10 percent to zero percent for the 2020 
MIPS payment year. We noted that we continue to have concerns about the 
level of familiarity with and understanding of cost measures among 
clinicians. We noted that we could use the additional year where the 
cost performance category would not affect the final score to increase 
understanding of the measures so that clinicians would be more 
comfortable with their role in reducing costs for their patients. In 
addition, we could use this additional year to develop and refine 
episode-based cost measures, which are cost measures that are focused 
on clinical conditions or procedures. We intend to propose in future 
rulemaking policies to adopt episode-based measures currently in 
development.
    Although we believed that reducing this weight could be appropriate 
given the level of understanding of the measures and the scoring 
standards, we noted that section 1848(q)(5)(E)(i)(II)(aa) of the Act 
requires the cost performance category to be assigned a weight of 30 
percent of the MIPS final score beginning in the 2021 MIPS payment 
year. We recognized that assigning a zero percent weight to the cost 
performance category for the 2020 MIPS payment year may not provide a 
smooth enough transition for integrating cost measures into MIPS and 
may not provide enough encouragement to clinicians to review their 
performance on cost measures. Therefore, we sought comment on keeping 
the weight of the cost performance category at 10 percent for the 2020 
MIPS payment year (82 FR 30048).
    We invited public comments on this proposal of a zero percent 
weighting for the cost performance category and the alternative option 
of a 10 percent weighting for the cost performance category for the 
2020 MIPS payment year (82 FR 30048).
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: Many commenters supported our alternative option to keep 
the weight of the cost performance category at 10 percent for the 2020 
MIPS payment year, as we previously finalized in the CY 2017 Quality 
Payment Program final rule. The commenters expressed concern that the 
statutorily mandated 30 percent weight of the cost performance category 
in the 2021 MIPS payment year would be too steep an increase from zero 
percent, and MIPS eligible clinicians would be unprepared. Some 
commenters indicated that they believed that cost measures are 
intrinsic measures of value and that clinicians can demonstrate value 
through lower costs. One commenter recommended that the cost 
performance category be weighted at 15 percent for the 2020 MIPS 
payment year.
    Response: We share the commenters' concerns about the increase in 
the weight of the cost performance category from zero percent in the 
2020 MIPS payment year to 30 percent in the 2021 MIPS payment year, 
which is statutorily required. We agree with the commenters that cost 
measures are an important component of value, and that weighting the 
cost category at 10 percent will help to provide a smoother transition 
for clinicians by giving them more time to experience cost measurement 
with the cost category having a lower relative weight of 10 percent. 
Furthermore, moving forward with a lower relative weight in 
anticipation of the requirement to go to 30 percent in the 2021 MIPS 
payment year will allow more time for the development of episode-based 
cost measures, which are being developed with substantial

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clinician input. We are therefore adopting our alternative option to 
maintain the 10 percent weight for the cost performance category for 
the 2020 MIPS payment year, as we finalized in the CY 2017 Quality 
Payment Program final rule (81 FR 77165).
    Comment: Many commenters supported our proposal to weight the cost 
performance category at zero percent of the final score for the 2020 
MIPS payment year. The commenters stated that MIPS eligible clinicians 
are still gaining familiarity with the scoring methodology and the cost 
measures and would appreciate additional time to review feedback 
reports. Some commenters supported the proposal because episode-based 
measures were not yet included and therefore many clinicians would not 
be measured in the cost performance category. Some commenters suggested 
that CMS use the additional time to continue to improve risk 
adjustment, attribution, and other components of cost measures.
    Response: We will continue to work to make clinicians more familiar 
with the measures and continue to refine the measures. However, we are 
concerned that not assigning any weight to the cost performance 
category when the weight is required to be at 30 percent in the third 
MIPS payment year will result in too dramatic a transition in a single 
year. We also agree with commenters that new episode-based cost 
measures will be an important part of the cost category, and intend to 
make future proposals about implementing episode-based measures as soon 
as they are developed.
    Comment: Several commenters stated that although the statute 
requires the cost performance category to be weighted at 30 percent of 
the final score in the third MIPS payment year, we should use 
flexibility in the statute to weight the cost performance category at 
zero percent or a percentage lower than 30 percent for the third MIPS 
payment year and for additional years in the future either by 
determining that there are no applicable measures in the cost 
performance category or using broader flexibility to reweight the 
performance categories. These commenters supported the zero percent 
weight for the 2020 MIPS payment year but believed that the cost 
performance category should not count towards the final score until 
clinicians have gained more experience with this category, episode-
based measures are more developed, and risk adjustment models are more 
robust.
    Response: While we understand the concerns of commenters, section 
1848(q)(5)(E) of the Act requires the cost performance category to be 
weighted at 30 percent of the final score beginning in the third MIPS 
payment year. We do not believe the statute affords us flexibility to 
adjust this prescribed weight, unless we determine there are not 
sufficient cost measures applicable and available to MIPS eligible 
clinicians under section 1848(q)(5)(F) of the Act. We believe that a 
clinician's influence on the costs borne by both patients and the 
Medicare program is an important component of measuring value as 
envisioned by the creation of the MIPS program. In addition, because of 
our concerns about the dramatic transition between the cost performance 
category being weighed at zero percent for a year and 30 percent for 
the next year, we are adopting our alternative to maintain the 10 
percent weight for the cost performance category for the 2020 MIPS 
payment year. We continue to work with clinicians to better understand 
the cost measures as they prepare for the category to be weighted at 30 
percent of the final score. We are seeking extensive input from 
clinicians on the development of episode-based measures and technical 
updates to existing measures in addition to providing feedback reports 
so that clinicians can better understand the measures.
    Comment: Several commenters recommended that the cost performance 
category be weighted at 10 percent in the 2020 MIPS payment year only 
for those clinicians who volunteer to be measured on cost. Other 
commenters expressed their support for a zero percent weighting but 
requested that clinicians be given information on how they would have 
scored under cost measurement.
    Response: We do not have the statutory authority to score cost 
measures on a voluntary basis under MIPS. Because the MIPS cost 
measures are calculated based on Medicare claims data and do not 
require additional reporting by clinicians, we are able to provide 
outreach and model scoring scenarios without clinicians volunteering to 
complete any actions. We are planning to provide feedback on both 
individual measures as well as the cost performance category to 
increase understanding and familiarity going into future years.
    Comment: Many commenters requested that CMS provide extensive 
feedback on cost measures and the cost performance category score to 
ensure that clinicians are best positioned for the cost performance 
category to be weighted at 30 percent of the final score for the 2021 
MIPS payment year.
    Response: We discuss in section II.C.9.a of this final rule with 
comment period our plans to provide performance feedback, including on 
cost measures. As noted there, we will also be providing information on 
newly developed episode-based measures which may become a part of the 
MIPS cost performance category in future years.
    Comment: A few commenters recommended that the cost performance 
category be weighted at zero percent for certain specialties or types 
of clinicians for an indefinite period of time because not enough 
measures are available for them. One commenter suggested that if at 
least one episode-based measure cannot be calculated for a clinician or 
group that they not be scored in the cost performance category.
    Response: We recognize that not every clinician will have cost 
measures attributed to them in the initial years of MIPS and therefore 
may not receive a cost performance category score. However, we do not 
believe that it is appropriate to exclude certain clinicians from cost 
measurement on the basis of their specialty if they are attributed a 
sufficient number of cases to meet the case minimum for the cost 
measure. We did not propose any episode-based measures for the 2018 
MIPS performance period. We address MIPS cost performance category 
scoring policies in section II.C.7.a.(3) of this final rule with 
comment period, but we did not propose any changes related to the 
minimum number of measures required to receive a cost performance 
category score. A MIPS eligible clinician must be attributed a 
sufficient number of cases for at least one cost measure, and that cost 
measure must have a benchmark, in order for the clinician to receive a 
cost performance category score (81 FR 77322 through 77323).
    Comment: One commenter recommended that small practices (defined as 
15 or fewer clinicians) not have the cost performance category 
contribute to the weight of their final score, at least until more 
valid and reliable measures are developed.
    Response: While we have a strong commitment to ensuring that small 
practices are able to participate in MIPS, we do not have the statutory 
authority to exempt small practices from the cost performance category. 
We have offered additional flexibility for small practices in a number 
of areas, including a small practice bonus that will be added to the 
final score for the 2020 MIPS payment year (see section II.C.7.b.(1)(c) 
of this final rule with comment period). Many of these policies are 
intended to recognize the different level of administrative or other 
support a small practice might have in comparison to a larger entity. 
Because the MIPS cost

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measures do not require reporting of data by clinicians other than the 
usual submission of claims, there is no additional administrative 
burden associated with being a small practice in the cost performance 
category. Furthermore, it is possible that some small practices will 
not have any cost measures applicable and available to them because 
they may not meet the case minimums for any of the cost measures. Other 
small practices may have a considerable volume of patients and wish to 
be rewarded for their commitment to reducing the cost of care.
    Comment: A few commenters recommended that the cost performance 
category be weighted at a percentage higher than zero percent but lower 
than 10 percent so that the cost performance category would have a 
limited contribution to the final score.
    Response: We are adopting our alternative of maintaining the cost 
performance category weight at 10 percent of the final score for the 
2020 MIPS payment year. We are doing so because we are concerned about 
the dramatic transition between a zero percent weight and the 30 
percent weight mandated for the 2021 MIPS payment year. We did receive 
many comments in favor of the 10 percent weight and do not believe that 
a weight below 10 percent will provide an easier transition to the 30 
percent weight for the 2021 MIPS payment year.
    Comment: Some commenters expressed general concern about our 
approach to measuring the cost performance category. Some suggested 
that cost measures should not be included if there are not quality 
measures for the same group of patients. A few commenters suggested 
that cost measures should only consider services that were personally 
provided or ordered by a clinician.
    Response: We have designed the Quality Payment Program to be 
flexible and allow clinicians to select quality measures that reflect 
their practice. We expect that most clinicians and groups will select 
measures based on the types of patients they typically see. Because the 
measures for the cost performance category are calculated based on 
Medicare claims submitted, we believe they will also reflect a 
clinician's practice. While we are finalizing cost measures that do not 
directly correspond to quality measures, we note that each performance 
category is weighted and combined to determine the final score. In that 
sense, we believe that we are measuring value by rewarding performance 
in quality while keeping down costs. We also believe that clinicians 
can influence the cost of services that they do not personally perform 
by improving care management with other clinicians and avoiding 
unnecessary services.
    Final Action: After consideration of the public comments, we are 
not finalizing our proposal to weight the cost performance category at 
zero percent of the final score for the 2020 MIPS payment year. We are 
instead adopting our alternative option to maintain the weight of the 
cost performance category at 10 percent of the final score for the 2020 
MIPS payment year as we finalized in the CY 2017 Quality Payment 
Program final rule (81 FR 77165).
(3) Cost Criteria
(a) Measures Proposed for the MIPS Cost Performance Category
(i) Background
    Under Sec.  414.1350(a), we specify cost measures for a performance 
period to assess the performance of MIPS eligible clinicians on the 
cost performance category. For the 2017 MIPS performance period, we 
will utilize 12 cost measures that are derived from Medicare 
administrative claims data. Two of these measures, the MSPB measure and 
total per capita cost measure, have been used in the VM (81 FR 77166 
through 77168), and the remaining 10 are episode-based measures that 
were included in the sQRURs in 2014 and 2015 (81 FR 77171 through 
77174).
    Section 1848(r) of the Act specifies a series of steps and 
activities for the Secretary to undertake to involve the physician, 
practitioner, and other stakeholder communities in enhancing the 
infrastructure for cost measurement, including for purposes of MIPS, 
which we summarized in detail in the CY 2018 Quality Payment Program 
proposed rule (82 FR 30048).
(ii) Total Per Capita Cost and MSPB Measures
    For the 2018 MIPS performance period and future performance 
periods, we proposed to include in the cost performance category the 
total per capita cost measure and the MSPB measure as finalized for the 
2017 MIPS performance period (82 FR 30048 through 30049). We referred 
readers to the description of these measures in the CY 2017 Quality 
Payment Program final rule (81 FR 77164 through 77171). We proposed to 
include the total per capita cost measure because it is a global 
measure of all Medicare Part A and Part B costs during the performance 
period. MIPS eligible clinicians are familiar with the total per capita 
cost measure because the measure has been used in the VM since the 2015 
payment adjustment period and performance feedback has been provided 
through the annual QRUR since 2013 for a subset of groups that had 20 
or more eligible professionals) and to all groups in the annual QRUR 
since 2014 and mid-year QRUR since 2015. We proposed to use the MSPB 
measure because many MIPS eligible clinicians will be familiar with the 
measure from the VM, where it has been included since the 2016 payment 
adjustment period and in annual QRUR since 2014 and the mid-year QRUR 
since 2015, or its hospital-specified version, which has been a part of 
the Hospital VBP Program since 2015. In addition to familiarity, these 
two measures cover a large number of patients and provide an important 
measurement of clinician contribution to the overall population that a 
clinician encounters.
    We did not propose any changes to the methodologies for payment 
standardization, risk adjustment, and specialty adjustment for these 
measures and refer readers to the CY 2017 Quality Payment Program final 
rule (81 FR 77164 through 77171) for more information about these 
methodologies.
    We noted that we will continue to evaluate cost measures that are 
included in MIPS on a regular basis and anticipate that measures could 
be added or removed, subject to rulemaking under applicable law, as 
measure development continues. We will also maintain the measures that 
are used in the cost performance category by updating specifications, 
risk adjustment, and attribution as appropriate. We anticipate 
including a list of cost measures for a given performance period in 
annual rulemaking.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: Many commenters opposed the inclusion of the total per 
capita cost measure and the MSPB measure as cost measures for the 2018 
MIPS performance period and future performance periods. Commenters 
expressed concern that these measures did not differentiate between 
services or circumstances that clinicians could control from those that 
they could not. The commenters stated that the MSPB measure had been 
developed for the hospital setting and had not been endorsed for use 
for clinician accountability by the NQF. The commenters stated that the 
total per capita cost measure had not been endorsed by the NQF. Some 
commenters recommended that these

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measures be eliminated when episode-based measures are made part of the 
program because episode-based measures are more focused on certain 
conditions.
    Response: Both the total per capita cost and MSPB measures were 
included in the QRURs and used in the VM for many years before the 
implementation of MIPS. These two measures cover a large number of 
patients and provide an important measurement of clinician contribution 
to the overall population that a clinician encounters. Like all of the 
cost measures that we have developed, we continue to refine these 
measures for improvement. If we find that episode-based measures would 
be an appropriate replacement for both of these measures, we would 
address that issue in future rulemaking. At this time, we believe that 
the total per capita and MSPB measures are tested and reliable for 
Medicare populations and are therefore the best measures available for 
the cost performance category. We are concurrently developing new 
episode-based cost measures with substantial clinician input, that we 
will consider for proposals in future rulemaking.
    Comment: Several commenters supported our proposal to include the 
total per capita cost measure and MSPB measure as cost measures for the 
2018 MIPS performance period. These commenters stated that these 
measures had been used in the legacy VM and would be applicable to many 
clinicians.
    Response: We appreciate the commenters for their support.
    Comment: A few commenters recommended that Part B drugs be excluded 
from the cost measures because Part D drugs are excluded. They 
suggested that including Part B drugs is unfair because it would 
penalize clinicians for prescribing or providing appropriate care.
    Response: We believe that clinicians play a key role in prescribing 
drugs for their patients and that the costs associated with drugs can 
be a significant contributor to the overall cost of caring for a 
patient. We do not believe it would be appropriate to remove the cost 
of Medicare Part B drugs from the cost measures, when other services 
that are ordered but not performed by clinicians, such as laboratory 
tests or diagnostic imaging, are included. Clinicians play a similar 
role in prescribing Part D drugs, and Part D drugs can also be a 
significant contributor to the overall cost of care. However, there are 
technical challenges that would need to be addressed to integrate Part 
D drug costs. Section 1848(q)(2)(B)(ii) of the Act requires CMS, to the 
extent feasible and applicable, to account for the cost of drugs under 
Medicare Part D as part of cost measurement under MIPS, and we will 
continue to explore the addition of this data in cost measures.
    Final Action: After consideration of the public comments, we are 
finalizing our proposal to include the total per capita cost and MSPB 
measures in the cost performance category for the 2018 MIPS performance 
period and future performance periods.
(iii) Episode-Based Measures
    Episode-based measures differ from the total per capita cost 
measure and MSPB measure because their specifications only include 
services that are related to the episode of care for a clinical 
condition or procedure (as defined by procedure and diagnosis codes), 
as opposed to including all services that are provided to a patient 
over a given period of time. For the 2018 MIPS performance period, we 
did not propose to include in the cost performance category the 10 
episode-based measures that we adopted for the 2017 MIPS performance 
period in the CY 2017 Quality Payment Program final rule (81 FR 77171 
through 77174). We instead will work to develop new episode-based 
measures, with significant clinician input, for future performance 
periods.
    We received extensive comments on our proposal to include 41 of 
these episode-based measures for the 2017 MIPS performance period, 
which we responded to in the CY 2017 Quality Payment Program final rule 
(81 FR 77171 through 77174). We also received additional comments after 
publication of that final rule with comment period about the decision 
to include 10 episode-based measures for the 2017 MIPS performance 
period. Although comments were generally in favor of the inclusion of 
episode-based measures in the future, there was also overwhelming 
stakeholder interest in more clinician involvement in the development 
of these episode-based measures as required by section 1848(r)(2) of 
the Act. Although there was an opportunity for clinician involvement in 
the development of some of the episode-based measures included for the 
2017 MIPS performance period, it was not as extensive as the process we 
are currently using to develop episode-based measures. We believe that 
the new episode-based measures, which we intend to propose in future 
rulemaking to include in the cost performance category for the 2019 
MIPS performance period, will be substantially improved by more 
extensive stakeholder feedback and involvement in the process.
    A draft list of care episodes and patient condition groups that 
could become episode-based measures used in the Quality Payment 
Program, along with trigger codes that would indicate the beginning of 
the episode, was posted for comment in December 2016 (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/Episode-Based-Cost-Measure-Development-for-the-Quality-Payment-Program.pdf). This 
material was informed by engagement with clinicians from over 50 
clinician specialty societies through a Clinical Committee formed to 
participate in cost measure development. Subsequently, Clinical 
Subcomittees have been formed to provide input from a diverse array of 
clinicians on identifying conditions and procedures for episode groups. 
For the first set of episode-based cost measures being developed, the 
Clinical Subcommittees have nearly 150 clinicians affiliated with 
nearly 100 national specialty societies, recommending which services or 
claims would be counted in episode costs. This will ensure that cost 
measures in development are directly informed by a substantial number 
of clinicians and members of specialty societies.
    In addition, a technical expert panel has met to provide oversight 
and guidance for our development of episode-based cost measures. The 
technical expert panel has offered recommendations for defining an 
episode group, assigning costs to the group, attributing episode groups 
to clinicians, risk adjusting episodes, and aligning cost and quality. 
This expert feedback has been built into the current cost measure 
development process.
    As this process continues, we are continuing to seek input from 
clinicians. We believe that episode-based measures will benefit from 
this comprehensive approach to development. In addition, because it is 
possible that the new episode-based measures under development could 
address similar conditions as those in the episode-based measures 
finalized for the 2017 MIPS performance period, we believe that it 
would be better to focus attention on the new episode-based measures, 
so that clinicians would not receive feedback or scores from two 
measures for the same patient condition or procedure. We will endeavor 
to have as many episode-based measures available as possible for the 
2019 MIPS performance period but will continue to develop measures for 
potential consideration in the more distant future.
    Although we did not propose to include any episode-based measures 
in

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calculating the cost performance category score for the 2020 MIPS 
payment year, we noted that we do plan to continue to provide 
confidential performance feedback to clinicians on their performance on 
episode-based measures developed under the processes required by 
section 1848(r)(2) of the Act as appropriate in order to increase 
familiarity with the concept of episode-based measurement as well as 
the specific episodes that could be included in determining the cost 
performance category score in the future. We recently provided an 
initial opportunity for clinicians to review their performance based on 
the new episode-based measures, as the measures are developed and as 
the information is available. We note that this feedback will be 
specific to the new episode-based measures that are developed under the 
process described above and may be presented in a different format than 
MIPS eligible clinicians' performance feedback as described in section 
II.C.9.a. of this final rule with comment period. However, our 
intention is to align the feedback as much as possible to ensure 
clinicians receive opportunities to review their performance on 
potential new episode-based measures for the cost performance category 
prior to the 2019 MIPS performance period. We are concerned that 
continuing to provide feedback on the older episode-based measures 
along with feedback on new episode-based measures will be confusing and 
a poor use of resources. Because we are focusing on development of new 
episode-based measures, our feedback on episode-based measures that 
were previously developed will discontinue after 2017, as these 
measures would no longer be maintained or reflect changes in diagnostic 
and procedural coding. We intend to provide feedback on newly developed 
episode-based measures as they become available in a new format around 
summer 2018. We noted that the feedback provided in the summer of 2018 
will go to those MIPS eligible clinicians for whom we are able to 
calculate the episode-based measures, which means it would be possible 
a clinician may not receive feedback on episode-based measures in both 
the fall of 2017 and the summer of 2018. We believe that receiving 
feedback on the new episode-based measures will support clinicians in 
their readiness for the 2019 MIPS performance period.
    As previously finalized in the in the CY 2017 Quality Payment 
Program final rule (81 FR 77173), the 10 episode-based measures (which 
we did not propose for the 2018 MIPS performance period) will be used 
for determining the cost performance category score for the 2019 MIPS 
payment year in conjunction with the MSPB measure and the total per 
capita cost measure, although the cost performance category score will 
be weighted at zero percent in that year.
    The following is a summary of the public comments received and our 
responses:
    Comment: Many commenters supported our decision not to propose for 
the 2018 MIPS performance period the 10 episode-based measures that 
will be used for the 2017 MIPS performance period. These commenters 
stated that they supported the focus on the development of new episode-
based measures that are currently being developed under section 
1848(r)(2) of the Act and agreed that there would be confusion if 
multiple versions of episode-based measures existed.
    Response: We appreciate the commenters for their support.
    Comment: Many commenters expressed support for episode-based 
measurement but concern about our stated plan to introduce new episode-
based measures to be used in the cost performance category beginning in 
next year's proposed rule. Many commenters expressed support for the 
process that had prioritized clinician involvement but were concerned 
that the measures would not be able to be tested or understood by 
clinicians prior to their introduction in the MIPS program. Some 
commenters recommended that episode-based measures be made available 
for feedback for at least a year before contributing to the cost 
performance category percent score. Some commenters recommended that 
cost measures not be included unless they were endorsed by the NQF or 
recommended by the MAP.
    Response: As part of our episode-based measure development, we are 
completing an extensive outreach initiative in the fall of 2017 to 
share performance information with many clinicians on the newly 
developed episode-based measures as part of field testing, a part of 
measure development. We believe these efforts go beyond the typical 
testing associated with many performance measures and should reveal 
issues that were not clear during the development, which also included 
many clinician experts. We did not make any specific proposals related 
to the inclusion of episode-based measures in future years, but this 
development work is intended to develop measures that could be used in 
the MIPS cost performance category. All measures that will be included 
in the program would be included in a future proposed rule, and we 
would discuss the assessment and testing of the measures at the time of 
their proposal. Although CMS is conducting a rigorous process to ensure 
that any new measure is rigorously reviewed before implementation, we 
believe it is in the interest of MIPS participants, particularly 
certain specialists, to have access to new episode based measures. We 
will consider the opportunity to submit measures that have been or may 
be adopted for the cost performance category for NQF endorsement and to 
the MAP review process in the future.
    Comment: A few commenters recommended specific clinical topics for 
episode-based measures, including oncology care, chronic care, care of 
the frail elderly, and rare disease. One commenter recommended that CMS 
consider a measure that focuses on adherence to clinical pathways, 
rather than using costs of care, because clinical pathways would 
differentiate care that is appropriate from care that is not.
    Response: We appreciate the suggestions for future development of 
episode-based measures and other measures. We will continue to endeavor 
to develop measures that capture the cost of care for as many different 
types of patients and clinicians as possible. We would also review 
potential different methodologies as appropriate.
    Comment: Several commenters recommended that episode-based measures 
be developed so that all drugs costs are considered in the same manner, 
rather than Medicare Part B drugs being included and Medicare Part D 
drugs being excluded. These commenters suggested the clinical 
interchangeability of these types of drugs and expressed concern that 
they would be considered differently in determining cost measures.
    Response: Section 1848(q)(2)(B)(ii) of the Act requires CMS, to the 
extent feasible and applicable, to account for the cost of drugs under 
Medicare Part D as part of cost measurement under MIPS. As stated in 
the CY 2017 Quality Payment Program final rule, we will continue to 
explore methods to add Part D drug costs into cost measures in the 
future. We believe that Part D drugs are a significant contributor to 
costs for both patients and the Medicare program and should be measured 
when technically feasible. Episode-based measures may include Part B 
drug costs if clinically appropriate as we believe these are an 
important component of health spending.
    Comment: One commenter requested that CMS develop a process to 
allow stakeholders to develop their own cost measures, rather than only 
relying on

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the CMS episode-based measure development. This commenter suggested 
that this would allow for more leadership from relevant specialties of 
medicine.
    Response: Although we continue to develop episode-based measures, 
we are open to considering other types of measures for use in the cost 
performance category. If an episode-based measure or cost measure were 
to be created by an external stakeholder, we may consider it for 
inclusion in the program along the same criteria that we have used to 
develop and refine other cost measures.
    Comment: A few commenters opposed the decision to not propose the 
inclusion of the 10 episode-based measures as cost performance category 
measures for the 2018 MIPS performance period and for future 
performance periods. These commenters suggested that clinicians would 
benefit from having these measures as part of their score even as new 
episode-based measures are developed.
    Response: Many of the 10 episode-based measures that are included 
for the 2019 MIPS payment year have similar topics to those in the new 
list of episode-based measures we are currently developing. We believe 
that continuing to use these measures would create confusion. 
Furthermore, we want to potentially include episode-based cost measures 
that have significant clinician input, which is a cornerstone of the 
new episode-based cost measures currently being developed.
    Comment: A few commenters recommended that, in addition to episode-
based measures, we include condition-specific total per capita cost 
measures that were used in the VM.
    Response: We are currently focusing on the development of episode-
based measures. We continue to believe that the total per capita cost 
measure we have adopted is inclusive of the four condition-specific 
total per capita cost measures that have been used under the VM 
(chronic obstructive pulmonary disease, congestive heart failure, 
coronary artery disease, and diabetes mellitus).
    Final Action: After consideration of the public comments, for the 
2018 MIPS performance period, we will not include in the cost 
performance category the 10 episode-based measures that we adopted for 
the 2017 performance period, and we do not anticipate proposing to 
include these measures in future performance periods. We will continue 
to work on development and outreach for new episode-based measures, 
such as those that are undergoing field testing in October 2017, and 
may propose to include them in MIPS as appropriate in future 
rulemaking.
(iv) Attribution
    In the CY 2017 Quality Payment Program final rule, we changed the 
list of primary care services that had been used to determine 
attribution for the total per capita cost measure by adding 
transitional care management (CPT codes 99495 and 99496) codes and a 
chronic care management code (CPT code 99490) (81 FR 77169). In the CY 
2017 Physician Fee Schedule final rule, we changed the payment status 
for two existing CPT codes (CPT codes 99487 and 99489) that could be 
used to describe care management from B (bundled) to A (active) meaning 
that the services would be paid under the Physician Fee Schedule (81 FR 
80349). The services described by these codes are substantially similar 
to those described by the chronic care management code that we added to 
the list of primary care services beginning with the 2017 performance 
period. We therefore proposed to add CPT codes 99487 and 99489, both 
describing complex chronic care management, to the list of primary care 
services used to attribute patients under the total per capita cost 
measure (82 FR 30050).
    We did not propose any changes to the attribution methods for the 
MSPB measure and referred readers to the CY 2017 Quality Payment 
Program final rule (81 FR 77168 through 77169) for more information.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: Some commenters supported the proposal to add CPT codes 
99487 and 99489 to the list of primary care services used to attribute 
patients under the total per capita cost measure, noting the similarity 
of these codes to other codes defined as primary care services for this 
purpose.
    Response: We appreciate the commenters for their support.
    Comment: Some commenters expressed concern that cost measures were 
being attributed to clinicians before patient relationship codes were 
being reported by clinicians. Some commenters recommended that cost 
measures not be used before the patient relationship codes are 
implemented and studied.
    Response: To facilitate the attribution of patients and episodes to 
one or more clinicians, section 1848(r)(3) of the Act requires the 
development of patient relationship categories and codes that define 
and distinguish the relationship and responsibility of a physician or 
applicable practitioner with a patient at the time of furnishing an 
item or service. In the CY 2018 Physician Fee Schedule proposed rule 
(82 FR 34129), we proposed to use certain HCPCS modifiers as the 
patient relationship codes. Section 1848(r)(4) of the Act requires 
claims submitted for items and services furnished by a physician or 
applicable practitioner on or after January 1, 2018, shall, as 
determined appropriate by the Secretary, include the applicable patient 
relationship code, in addition to other information. We proposed (82 FR 
34129) that for at least an initial period while clinicians gain 
familiarity, reporting the HCPCS modifiers on claims would be 
voluntary, and the use and selection of the modifiers would not be a 
condition of payment. The statute requires us to include the cost 
performance category in the MIPS program, and thus, we cannot delay the 
use of cost measures in MIPS until after the patient relationship codes 
have been implemented, as recommended by the commenters. However, we 
may consider future changes to our attribution methods for cost 
measures based on the patient relationship codes that will be reported 
on claims.
    Comment: One commenter recommended that services provided in a 
nursing facility (POS 32) not be included for purposes of attribution 
under the total per capita cost measure. One commenter recommended that 
services provided in a skilled nursing home facility (POS 31) continue 
to be excluded for purposes of attribution under the total per capita 
cost measure.
    Response: Patients in a skilled nursing home facility (SNF) (POS 
31) require more frequent practitioner visits--often from 1 to 3 times 
a week. In contrast, patients in nursing facilities (NFs) (POS 32) are 
almost always permanent residents and generally receive their primary 
care services in the facility for the duration of their life. On the 
other hand, patients in an NF (POS 32) are usually seen every 30 to 60 
days unless medical necessity dictates otherwise. We believe this 
distinction is important enough to treat these sites of service 
differently in terms of attribution for the total per capita cost 
measure. Services provided in POS 31 are not included in the definition 
of primary care services used for the total per capita cost measure, 
but services provided in POS 32 are. We will continue to evaluate 
attribution methods as part of measure development and maintenance.
    Comment: One commenter opposed the addition of complex chronic care 
management codes because palliative

[[Page 53647]]

care physicians often bill for the services, but serve in a consulting 
role as opposed to serving as a primary care clinician.
    Response: We believe that the attribution model that assigns 
patients on the basis of a plurality of services would not assign 
patients for the purposes of the total per capita cost measure on the 
basis of a single visit, unless that patient had also not seen a 
primary care clinician during the year. We believe these codes are 
consistent with other services typically provided by primary care 
clinicians.
    Comment: Many commenters expressed general concerns about 
attribution methods, stating that they were not well understood, were 
not properly tested, and were unfair. These commenters encouraged CMS 
to improve or perfect attribution methods.
    Response: We will continue to work to improve attribution methods 
as we develop the measures and methods that are part of the cost 
performance category. We do not use a single attribution method--
instead the attribution method is linked to a measure and attempts to 
best identify the clinician who may have influenced the spending for a 
patient, whether it be all spending in a year or a more narrow set of 
spending in a defined period. As we continue our work to develop 
episode-based measures and refine the two cost measures included for 
the 2018 MIPS performance period, we will work to explain the 
methodology for attribution and how it works in relation to the measure 
and the scoring methodology.
    Final Action: After consideration of the public comments, we are 
finalizing our proposal to add CPT codes 99487 and 99489 to the list of 
primary care services used to attribute patients under the total per 
capita cost measure.
(v) Reliability
    In the CY 2017 Quality Payment Program final rule (81 FR 77169 
through 77170), we finalized a reliability threshold of 0.4 for 
measures in the cost performance category. Reliability is an important 
evaluation for cost measures to ensure that differences in performance 
are not the result of random variation. In the proposed rule, we 
provided a summary of the importance of reliability in measurement and 
how high reliability must be balanced with other goals, such as 
measuring where there is significant variation and ensuring that cost 
measurement is not limited to large groups with large case volume (82 
FR 30050). Although we did not propose any adjustments to our 
reliability policies, we did receive a number of comments on issues 
related to reliability which we will consider as part of future 
rulemaking. We will continue to evaluate reliability as we develop new 
measures and to ensure that our measures meet an appropriate standard.
(b) Attribution for Individuals and Groups
    We did not propose any changes for how we attribute cost measures 
to individual and group reporters. We refer readers to the CY 2017 
Quality Payment Program final rule for more information (81 FR 77175 
through 77176). Although we did not propose any adjustments to our 
attribution policies, we did receive a number of comments on issues 
related to attribution which we will consider as part of future 
rulemaking.
(c) Incorporation of Cost Measures With SES or Risk Adjustment
    Both measures proposed for inclusion in the cost performance 
category for the 2018 MIPS performance period are risk adjusted at the 
measure level. Although the risk adjustment of the 2 measures is not 
identical, in both cases it is used to recognize the higher risk 
associated with demographic factors (such as age) or certain clinical 
conditions. We recognize that the risks accounted for with this 
adjustment are not the only potential attributes that could lead to a 
higher cost patient. Stakeholders have pointed to many other factors 
such as income level, race, and geography that they believe contribute 
to increased costs. These issues and our plans for attempting to 
address them are discussed in length in section II.C.7.b.(1)(a) of this 
final rule with comment period. While we did not propose any changes to 
address risk adjustment for cost measures in this rule, we continue to 
believe that this is an important issue and it will be considered 
carefully in the development of future cost measures and for the 
overall cost performance category. Although we did not propose any 
adjustments to our policies on incorporating cost measures with SES or 
risk adjustment, we did receive a number of comments which we will 
consider as part of future rulemaking.
(d) Incorporation of Cost Measures With ICD-10 Impacts
    In the CY 2018 Quality Payment Program proposed rule (82 FR 30098), 
we discussed our proposal to assess performance on any measures 
impacted by ICD-10 updates based only on the first 9 months of the 12-
month performance period. Because the total per capita cost and MSPB 
measures include costs from all Medicare Part A and B services, 
regardless of the specific ICD-10 codes that are used on claims, and do 
not assign patients based on ICD-10, we do not anticipate that any 
measures for the cost performance category would be affected by this 
ICD-10 issue during the 2018 MIPS performance period. However, as we 
continue our plans to expand cost measures to incorporate episode-based 
measures, ICD-10 changes could become important. Episode-based measures 
may be opened (triggered) by and may assign services based on ICD-10 
codes. Therefore, a change to ICD-10 coding could have a significant 
effect on an episode-based measure. Changes to ICD-10 codes will be 
incorporated into the measure specifications on a regular basis through 
the measure maintenance process. Please refer to section 
II.C.7.a.(1)(c) of this final rule with comment period for a summary of 
the comments and our response on this issue.
(e) Application of Measures to Non-Patient Facing MIPS Eligible 
Clinicians
    We did not propose changes to the policy we finalized in the CY 
2017 Quality Payment Program final rule (81 FR 77176) that we will 
attribute cost measures to non-patient facing MIPS eligible clinicians 
who have sufficient case volume, in accordance with the attribution 
methodology. Although we did not propose any adjustments to our 
attribution of cost measures to non-patient facing MIPS eligible 
clinicians with sufficient case volume policies, we did receive a few 
comments which we will consider as part of future rulemaking.
    Section 1848(q)(2)(C)(iv) of the Act requires the Secretary to 
consider the circumstances of professional types who typically furnish 
services without patient facing interaction (non-patient facing) when 
determining the application of measures and activities. In addition, 
this section allows the Secretary to apply alternative measures or 
activities to non-patient facing MIPS eligible clinicians that fulfill 
the goals of a performance category. Section 1848(q)(5)(F) of the Act 
allows the Secretary to re-weight MIPS performance categories if there 
are not sufficient measures and activities applicable and available to 
each type of MIPS eligible clinician involved.
    We believe that non-patient facing clinicians are an integral part 
of the care team and that their services do contribute to the overall 
costs but at this time we believe it better to focus on the development 
of a comprehensive system of episode-based measures which focus

[[Page 53648]]

on the role of patient-facing clinicians. Accordingly, for the 2018 
MIPS performance period, we did not propose alternative cost measures 
for non-patient facing MIPS eligible clinicians or groups. This means 
that non-patient facing MIPS eligible clinicians or groups are unlikely 
to be attributed any cost measures that are generally attributed to 
clinicians who have patient-facing encounters with patients. Therefore, 
we anticipate that, similar to MIPS eligible clinicians or groups that 
do not meet the required case minimums for any cost measures, many non-
patient facing MIPS eligible clinicians may not have sufficient cost 
measures applicable and available to them and would not be scored on 
the cost performance category under MIPS.
    We will continue to explore methods to incorporate non-patient 
facing clinicians into the cost performance category in the future.
(f) Facility-Based Measurement as It Relates to the Cost Performance 
Category
    In the CY 2018 Quality Payment Program proposed rule (82 FR 30123), 
we discussed our proposal to implement section 1848(q)(2)(C)(ii) of the 
Act by assessing clinicians who meet certain requirements and elect 
participation based on the performance of their associated hospital in 
the Hospital VBP Program. We refer readers to section II.C.7.a.(4) of 
this final rule with comment period for full details on the final 
policies related to facility-based measurement, including the measures 
and how the measures are scored, for the cost performance category.
e. Improvement Activity Criteria
(1) Background
    Section 1848(q)(2)(C)(v)(III) of the Act defines an improvement 
activity as an activity that relevant eligible clinician organizations 
and other relevant stakeholders identify as improving clinical practice 
or care delivery, and that the Secretary determines, when effectively 
executed, is likely to result in improved outcomes. Section 
1848(q)(2)(B)(iii) of the Act requires the Secretary to specify 
improvement activities under subcategories for the performance period, 
which must include at least the subcategories specified in section 
1848(q)(2)(B)(iii)(I) through (VI) of the Act, and in doing so to give 
consideration to the circumstances of small practices, and practices 
located in rural areas and geographic health professional shortage 
areas (HPSAs).
    Section 1848(q)(2)(C)(iv) of the Act generally requires the 
Secretary to give consideration to the circumstances of non-patient 
facing individual MIPS eligible clinicians or groups and allows the 
Secretary, to the extent feasible and appropriate, to apply alternative 
measures and activities to such individual MIPS eligible clinicians and 
groups.
    Section 1848(q)(2)(C)(v) of the Act required the Secretary to use a 
request for information (RFI) to solicit recommendations from 
stakeholders to identify improvement activities and specify criteria 
for such improvement activities, and provides that the Secretary may 
contract with entities to assist in identifying activities, specifying 
criteria for the activities, and determining whether individual MIPS 
eligible clinicians or groups meet the criteria set. For a detailed 
discussion of the feedback received from the MIPS and APMs RFI, see the 
CY 2017 Quality Payment Program 2017 final rule (81 FR 77177).
    In the CY 2017 Quality Payment Program final rule (81 FR 77178), we 
defined improvement activities at Sec.  414.1305 as an activity that 
relevant MIPS eligible clinicians, organizations and other relevant 
stakeholders identify as improving clinical practice or care delivery 
and that the Secretary determines, when effectively executed, is likely 
to result in improved outcomes.
    In the CY 2017 Quality Payment Program final rule (81 FR 77199), we 
solicited comments on activities that would advance the usage of health 
IT to support improvement activities for future consideration. Please 
refer to the CY 2018 Quality Payment Program proposed rule (82 FR 
30052) for a full discussion of the public comments we received in 
response to the CY 2017 Quality Payment Program final rule and our 
responses provided on activities that would advance the usage of health 
IT to support improvement activities.
    In the CY 2018 Quality Payment Program proposed rule (82 FR 30052), 
we sought comment on how we might provide flexibility for MIPS eligible 
clinicians to effectively demonstrate improvement through health IT 
usage while also measuring such improvement for future consideration. 
We received many comments on this topic and will take them into 
consideration for future rulemaking.
(2) Contribution to the Final Score
(i) Patient-Centered Medical Home
    In the CY 2017 Quality Payment Program final rule (81 FR 77179 
through 77180), we finalized at Sec.  414.1355 that the improvement 
activities performance category would account for 15 percent of the 
final score. We also finalized at Sec.  414.1380(b)(3)(iv) criteria for 
recognition as a certified patient-centered medical home or comparable 
specialty practice. Since then, it has come to our attention that the 
common terminology utilized in the general medical community for 
``certified'' patient-centered medical home is ``recognized'' patient-
centered medical home.
    Therefore, in order to provide clarity, in the CY 2018 Quality 
Payment Program proposed rule (82 FR 30052), we proposed that the term 
``recognized'' be accepted as equivalent to the term ``certified'' when 
referring to the requirements for a patient-centered medical home to 
receive full credit for the improvement activities performance category 
for MIPS. Specifically, we proposed to revise Sec.  414.1380(b)(3)(iv) 
to provide that a MIPS eligible clinician or group in a practice that 
is certified or recognized as a patient-centered medical home or 
comparable specialty practice, as determined by the Secretary, receives 
full credit for performance on the improvement activities performance 
category. A practice is certified or recognized as a patient-centered 
medical home if it meets any of the criteria specified under Sec.  
414.1380(b)(3)(iv).
    We invited public comment on this proposal.
    Comment: A few commenters supported the proposed expansion of the 
patient-centered medical home definition, to include both medical homes 
that are ``certified'' and those that are ``recognized.'' These 
commenters noted that inclusion of both terms aligns with the 
terminology used by various organizations and states that have patient-
centered medical home programs that may be eligible for full credit in 
the improvement activities performance category.
    Response: We thank the commenters for their support.
    Comment: One commenter stated that in the CY 2017 Quality Payment 
Program final rule, the documented recognition as a patient-centered 
medical home from an accredited body combined with continual 
improvements was listed as already receiving credit in the improvement 
activity performance category.
    Response: We believe the commenter is referring to our discussion 
in the CY 2017 Quality Payment Program final rule (81 FR 77179 through 
77180), where we finalized at Sec.  414.1380 an expanded definition of 
what is acceptable for recognition as a certified-

[[Page 53649]]

patient centered medical home or comparable specialty practice. We 
recognized a MIPS eligible clinician or group as being a certified 
patient-centered medical home or comparable specialty practice if they 
have achieved certification or accreditation as such from a national 
program, or they have achieved certification or accreditation as such 
from a regional or state program, private payer or other body that 
certifies at least 500 or more practices for patient-centered medical 
home accreditation or comparable specialty practice certification. In 
the CY 2018 Quality Payment Program proposed rule, we did not propose 
any substantive changes to that definition. However, for the sake of 
clarity we proposed that we will accept the designation of 
``recognized'' as equivalent to the designation of ``certified'' when 
referring to the requirements for a patient-centered medical home or 
comparable specialty practice to receive full credit for the 
improvement activities performance category for MIPS and also to update 
Sec.  414.1380(b)(3)(iv) to reflect this. Our intention behind this 
proposal was to reflect common terminology utilized in the general 
medical community--that ``certified'' patient-centered medical home is 
equivalent to ``recognized'' patient-centered medical home. A practice 
is certified or recognized as a patient-centered medical home if it 
meets any of the criteria specified under Sec.  414.1380(b)(3)(iv).
    Comment: Several commenters provided comments that were not related 
to our proposal to accept the designation of ``recognized'' as 
equivalent to the designation of ``certified'' when referring to the 
requirements for a patient-centered medical home or comparable 
specialty practice to receive full credit for the improvement 
activities performance category for MIPS. They are summarized here. 
Some commenters recommended that CMS consider other models as patient-
centered medical homes for full credit in this performance category. 
These commenters suggested that CMS consider full credit to those MIPS 
eligible clinicians and groups participating in models such as a 
Patient Centered Medical Neighborhood (PCMN), participation in a 
Certified Community Behavioral Health Clinic (CCBHC) or a Medicaid 
Section 2703 Health Home, or Blue Distinction[supreg] Total Care. Other 
commenters suggested that CMS establish a policy to offer full auto-
credit to any practice that achieves National Committee for Quality 
Assurance (NCQA) recognition by December 31st of a given performance 
year, since NCQA requires that practices seeking patient-centered 
medical home and patient-centered specialty practice (PCSP) recognition 
perform the appropriate activities for a minimum of 90 days. Further, 
these commenters recommended that this policy should extend to any 
other approved patient-centered medical home programs that use a 90-day 
look-back period.
    Response: We acknowledge the commenter's suggestions that we 
consider additional models as patient-centered medical homes for full 
credit in this performance category. In the CY 2017 Quality Payment 
Program final rule (81 FR 77180), we previously stated that we 
recognize a MIPS eligible clinician or group as being a certified 
patient-centered medical home or comparable specialty practice if they 
have achieved certification or accreditation as such from a national 
program, or they have achieved certification or accreditation as such 
from a regional or state program, private payer or other body that 
certifies at least 500 or more practices for patient-centered medical 
home accreditation or comparable specialty practice certification. We 
went on to state that examples of nationally recognized accredited 
patient-centered medical homes are: (1) The Accreditation Association 
for Ambulatory Health Care; (2) the National Committee for Quality 
Assurance (NCQA) Patient-Centered Medical Home; (3) The Joint 
Commission Designation; or (4) the Utilization Review Accreditation 
Commission (URAC) (81 FR 77180). We finalized that the criteria for 
being a nationally recognized accredited patient-centered medical home 
are that it must be national in scope and must have evidence of being 
used by a large number of medical organizations as the model for their 
patient-centered medical home (81 FR 77180). We also stated that we 
will also provide full credit for the improvement activities 
performance category for a MIPS eligible clinician or group that has 
received certification or accreditation as a patient-centered medical 
home or comparable specialty practice from a national program or from a 
regional or state program, private payer, or other body that 
administers patient-centered medical home accreditation and certifies 
500 or more practices for patient-centered medical home accreditation 
or comparable specialty practice certification (81 FR 77180). We note, 
however, that in the CY 2018 Quality Payment Program proposed rule we 
did not propose any changes to the definition of what is acceptable for 
recognition as a certified patient-centered medical home or comparable 
specialty practice that we finalized in the CY 2017 Quality Payment 
Program final rule (81 FR 77180) and codified under Sec.  
414.1380(b)(3)(iv). Without more information, we cannot provide 
information as to whether the suggested entities fall within our 
previously established definition above. Furthermore, while we are not 
considering any changes to this definition and criteria for the CY 2018 
performance period, we may consider commenters' suggestions as we craft 
policy for future rulemaking. Moreover, we would like to make clear 
that credit is not automatically granted; MIPS eligible clinicians and 
groups must attest in order to receive the credit (81 FR 77181) which 
is codified at Sec.  414.1360.
    Final Action: After consideration of the public comments received, 
we are finalizing, as proposed, our proposals: (1) That the term 
``recognized'' be accepted as equivalent to the term ``certified'' when 
referring to the requirements for a patient-centered medical home to 
receive full credit for the improvement activities performance category 
for MIPS; and (2) to update Sec.  414.1380(b)(3)(iv) to reflect this 
change.
(ii) Weighting of Improvement Activities
    As previously explained in the CY 2017 Quality Payment Program 
final rule (81 FR 77194), we believe that high weighting should be used 
for activities that directly address areas with the greatest impact on 
beneficiary care, safety, health, and well-being. In the CY 2017 
Quality Payment Program final rule (81 FR 77198), we requested 
commenters' specific suggestions for additional activities or 
activities that may merit additional points beyond the ``high'' level 
for future consideration.
    Comment: Several commenters urged CMS to increase the overall 
number of high-weighted activities in this performance category. Some 
commenters recommended additional criteria for designating high-
weighted activities, such as an improvement activity's impact on 
population health, medication adherence, and shared decision-making 
tools, and encouraged CMS to be more transparent in our weighting 
decisions. Several commenters recommended that CMS weight registry-
related activities as high, and suggested that we award individual MIPS 
eligible clinicians and groups in APMs full credit in this performance 
category. The commenters also offered many recommendations for changing

[[Page 53650]]

current medium-weighted activities to high and offered many specific 
suggestions for new high-weighted improvement activities.
    Response: After review and consideration of comments in the CY 2017 
Quality Payment Program final rule, while we did not propose changes to 
our approach for weighting improvement activities in the CY 2018 
Quality Payment Program proposed rule (82 FR 30052), we will take the 
additional criteria suggested by commenters for designating high-
weighted activities into consideration in future rulemaking. We did 
however, propose new, high-weighted as well as new medium weighted 
activities, in Table F in the Appendix of the proposed rule. We refer 
readers to Table F in the Appendix of this final rule with comment 
period where we are finalizing new activites, and Table G in the same 
Appendix where we are finalizing changes to existing improvement 
activities.
    For MIPS eligible clinicians participating in MIPS APMs, in the CY 
2017 Quality Payment Program final rule (81 FR 77185) we finalized a 
policy to reduce reporting burden through the APM scoring standard for 
this performance category to recognize improvement activities work 
performed through participation in MIPS APMs. This policy is codified 
at Sec.  414.1370(g)(3), and we refer readers to the CY 2017 Quality 
Payment Program final rule for further details on reporting and scoring 
this performance category under the APM Scoring Standard (81 FR 77259 
through 77260). In the CY 2018 Quality Payment Program proposed rule, 
we did not propose any changes to these policies.
    We received many comments on this topic and will take them into 
consideration for future rulemaking.
(3) Improvement Activities Data Submission Criteria
(a) Submission Mechanisms
(i) Generally
    In the CY 2017 Quality Payment Program final rule (81 FR 77180), we 
discussed that for the transition year of MIPS, we would allow for 
submission of data for the improvement activities performance category 
using the qualified registry, EHR, QCDR, CMS Web Interface, and 
attestation data submission mechanisms through attestation. 
Specifically, in the CY 2017 Quality Payment Program final rule (81 FR 
77180), we finalized a policy that regardless of the data submission 
method, with the exception of MIPS eligible clinicians in MIPS APMs, 
all individual MIPS eligible clinicians or groups must select 
activities from the Improvement Activities Inventory. In addition, we 
codified at Sec.  414.1360, that for the transition year of MIPS, all 
individual MIPS eligible clinicians or groups, or third party 
intermediaries such as health IT vendors, QCDRs and qualified 
registries that submit on behalf of an individual MIPS eligible 
clinician or group, must designate a ``yes'' response for activities on 
the Improvement Activities Inventory. We also codified at Sec.  
414.1360 that in the case where an individual MIPS eligible clinician 
or group is using a health IT vendor, QCDR, or qualified registry for 
their data submission, the individual MIPS eligible clinician or group 
will validate the improvement activities that were performed, and the 
health IT vendor, QCDR, or qualified registry would submit on their 
behalf.
    We would like to maintain stability in the Quality Payment Program 
and continue these policies into future years. In the CY 2018 Quality 
Payment proposed rule (82 FR 30053), we proposed to update Sec.  
414.1360 for the transition year of MIPS and future years, to reflect 
that all individual MIPS eligible clinicians or groups, or third party 
intermediaries such as health IT vendors, QCDRs and qualified 
registries that submit on behalf of an individual MIPS eligible 
clinician or group, must designate a ``yes'' response for activities on 
the Improvement Activities Inventory. We note that these are the same 
requirements as previously codified for the transition year; 
requirements for the transition year remain unchanged. We merely 
proposed to extend the same policies for future years.
    In addition, in the case where an individual MIPS eligible 
clinician or group is using a health IT vendor, QCDR, or qualified 
registry for their data submission, we proposed that the MIPS eligible 
clinician or group will certify all improvement activities were 
performed and the health IT vendor, QCDR, or qualified registry would 
submit on their behalf (82 FR 30053). In summary, we proposed to 
continue our previously established policies for future years and to 
generally apply our group policies to virtual groups. Furthermore, we 
refer readers to the CY 2018 Quality Payment Program proposed rule at 
(82 FR 30029) and section II.C.4.d. of this final rule, where we are 
finalizing to generally apply our group policies to virtual groups.
    While we previously codified at Sec.  414.1325(d) in the CY 2017 
Quality Payment Program final rule that individual MIPS eligible 
clinicians and groups may only use one submission mechanism per 
performance category, (81 FR 77275), in section II.C.6.a.(1) of this 
final rule with comment period, we are finalizing our proposal, with 
modification, to revise Sec.  414.1325(d) for purposes of the 2021 MIPS 
payment year and future years to allow individual MIPS eligible 
clinicians and groups to submit measures and activities, as applicable, 
via as many submission mechanisms as necessary to meet the requirements 
of the quality, improvement activities, or advancing care information 
performance categories. We refer readers to section II.C.6.a.(1) of 
this final rule with comment period for discussion of this proposal as 
finalized.
    We also included a designation column in the Improvement Activities 
Inventory at Table H in the Appendix of the CY 2017 Quality Payment 
Program final rule (81 FR 77817) that indicated which activities 
qualified for the advancing care information bonus codified at Sec.  
414.1380. In future updates to the Improvement Activities Inventory, we 
intend to continue to indicate which activities qualify for the 
advancing care information performance category bonus.
    We invited public comment on our proposals.
    Comment: A few commenters expressed support for our proposal that 
for the transition year of MIPS and future years, all individual MIPS 
eligible clinicians or groups, or third party intermediaries such as 
health IT vendors, QCDRs, and qualified registries that submit on 
behalf of an individual MIPS eligible clinician or group, must 
designate a ``yes'' response for activities on the Improvement 
Activities Inventory, and that where an individual MIPS eligible 
clinician or group is using a health IT vendor, QCDR, or qualified 
registry for their data submission, the MIPS eligible clinician or 
group must certify all improvement activities were performed and the 
health IT vendor, QCDR, or qualified registry would submit on their 
behalf.
    Response: We thank the commenters for their support. We realize the 
way the proposal was worded may have caused some potential confusion. 
Therefore, we are clarifying here that our proposal merely extends the 
same requirements, as previously codified for the transition year, to 
future years; requirements for the transition year remain unchanged.
    Comment: One commenter urged CMS to refer to registries more 
broadly, rather than using the term ``QCDR,'' noting that many 
qualified registries are in use by clinicians, even though these may 
not have received official QCDR

[[Page 53651]]

status for one reason or another. Another commenter requested that CMS 
consider allowing other third parties that may be collecting 
information that is indicative of completion of an improvement activity 
to submit data to CMS, suggesting that for example, an organization 
that awards continuing medical education (CME) credits that qualify as 
improvement activities could submit a list of MIPS eligible clinicians 
who received qualifying CME credit directly to CMS.
    Response: We note that the terms ``qualified registry'' and 
``QCDR'' are defined terms for the purposes of MIPS, as codified at 
Sec.  414.1400. We refer readers to section II.C.10. of this final rule 
with comment period for a detailed discussion of third party 
intermediaries. While we recognize that there are other registries that 
are not considered MIPS qualified registry or QCDRs, those registries 
have the option to become a MIPS QCDR using the process finalized in 
the CY 2017 Quality Payment Program final rule (81 FR 77365), or 
qualify as a MIPS registry using the process finalized at 81 FR 77383 
in that same final rule. If an organization becomes a MIPS qualified 
registry or QCDR then they could submit MIPS data to us.
    Final Action: After consideration of the public comments we 
received, we are finalizing our proposals, with clarification, to 
continue our previously established policies for future years. 
Specifically: (1) For purposes of MIPS Year 2 and future years, MIPS 
eligible clinicians or groups must submit data on MIPS improvement 
activities in one of the following manners: Via qualified registries; 
EHR submission mechanisms; QCDR, CMS Web Interface; or attestation. Our 
proposal language may have potentially caused some confusion, because 
it included the transition year; however, we are clarifying here that 
policies were previously established for that year and remain 
unchanged. We are also finalizing, as proposed: (2) For activities that 
are performed for at least a continuous 90 days during the performance 
period, MIPS eligible clinicians must submit a yes response for 
activities within the Improvement Activities Inventory; and (3) that 
Sec.  414.1360 will be updated to reflect these changes.
(ii) Group Reporting
    In the CY 2017 Quality Payment Program final rule (81 FR 77181), we 
clarified that if one MIPS eligible clinician (NPI) in a group 
completed an improvement activity, the entire group (TIN) would receive 
credit for that activity. In addition, we specified that all MIPS 
eligible clinicians reporting as a group would receive the same score 
for the improvement activities performance category if at least one 
clinician within the group is performing the activity for a continuous 
90 days in the performance period. We refer readers to section 
II.C.4.d. of this final rule with comment period, where we are 
finalizing to generally apply our group policies to virtual groups. We 
did not propose any changes to our group reporting policies in the 
proposed rule. However, in the CY 2017 Quality Payment Program proposed 
rule (82 FR 30053), we requested comment for future consideration on 
whether we should establish a minimum threshold (for example, 50 
percent) of the clinicians (NPIs) that must complete an improvement 
activity in order for the entire group (TIN) to receive credit in the 
improvement activities performance category in future years. In 
addition, we requested comments for future consideration on recommended 
minimum threshold percentages and whether we should establish different 
thresholds based on the size of the group. In the proposed rule, (82 FR 
30053), we noted that we are concerned that while establishing any 
specific threshold for the percentage of NPIs in a TIN that must 
participate in an improvement activity for credit will incentivize some 
groups to move closer to the threshold, it may have the unintended 
consequence of incentivizing groups who are exceeding the threshold to 
gravitate back toward the threshold. Therefore, we requested comments 
for future consideration on how to set this threshold while maintaining 
the goal of promoting greater participation in an improvement activity.
    Additionally, we noted in the CY 2017 Quality Payment Program final 
rule (81 FR 77197) that we intended, in future years, to score the 
improvement activities performance category based on performance and 
improvement, rather than simple attestation. In the CY 2018 Quality 
Payment Program proposed rule (82 FR 30053), we sought comment on how 
we could measure performance and improvement for future consideration; 
we were especially interested in ways to measure performance without 
imposing additional burden on eligible clinicians, such as by using 
data captured in eligible clinicians' daily work.
    We received many comments on these topics and will take them into 
consideration as we craft for future policies.
(b) Submission Criteria
(i) Background
    In the CY 2017 Quality Payment Program final rule (81 FR 77185), we 
finalized at Sec.  414.1380 to set the improvement activities 
submission criteria under MIPS, to achieve the highest potential score, 
at two high-weighted improvement activities or four medium-weighted 
improvement activities, or some combination of high and medium-weighted 
improvement activities. While the minimum reporting period for one 
improvement activity is 90 days, the maximum frequency with which an 
improvement activity may be reported would be once during the 12-month 
performance period (81 FR 77185). In addition, we refer readers to 
section II.C.4.d. of this final rule with comment period, where we are 
finalizing to generally apply group policies to virtual groups.
    In the CY 2017 Quality Payment Program final rule (81 FR 77185), we 
established exceptions to the above for: Small practices; practices 
located in rural areas; practices located in geographic HPSAs; non-
patient facing individual MIPS eligible clinicians or groups; and 
individual MIPS eligible clinicians and groups that participate in a 
MIPS APM or a patient-centered medical home submitting in MIPS. 
Specifically, for individual MIPS eligible clinicians and groups that 
are small practices, practices located in rural areas or geographic 
HPSAs, or non-patient facing individual MIPS eligible clinicians or 
groups, to achieve the highest score, one high-weighted or two medium-
weighted improvement activities are required (81 FR 77185). For these 
individual MIPS eligible clinicians and groups, in order to achieve 
one-half of the highest score, one medium-weighted improvement activity 
is required (81 FR 77185).
    In the CY 2017 Quality Payment Program final rule (81 FR 77185), we 
finalized that under the APM scoring standard, all clinicians 
identified on the Participation List of an APM receive at least one-
half of the highest score applicable to the MIPS APM. To develop the 
improvement activities score assigned to each MIPS APM, we compare the 
requirements of the specific MIPS APM with the list of activities in 
the Improvement Activities Inventory and score those activities in the 
same manner that they are otherwise scored for MIPS eligible clinicians 
(81 FR 77185). If by our assessment the MIPS APM does not receive the 
maximum improvement activities performance category score then the APM 
entity can submit additional

[[Page 53652]]

improvement activities (81 FR 77185). All other individual MIPS 
eligible clinicians or groups that we identify as participating in APMs 
that are not MIPS APMs will need to select additional improvement 
activities to achieve the improvement activities highest score (81 FR 
77185). We did not propose any changes to these policies; we refer 
readers to section II.C.6.g. of this final rule with comment period for 
further discussion of the APM scoring standard.
    We received many comments on this topic and will take them into 
consideration for future rulemaking.
(ii) Patient-Centered Medical Homes or Comparable Specialty Practices
    In the CY 2017 Quality Payment Program final rule (81 FR 77185), we 
finalized at Sec.  414.1380(b)(3)(iv) to provide full credit for the 
improvement activities performance category, as required by law, for an 
individual MIPS eligible clinician or group that has received 
certification or accreditation as a patient-centered medical home or 
comparable specialty practice from a national program or from a 
regional or state program, private payer or other body that administers 
patient-centered medical home accreditation and certifies 500 or more 
practices for patient-centered medical home accreditation or comparable 
specialty practice certification, or for an individual MIPS eligible 
clinician or group that is a participant in a medical home model. We 
noted in the CY 2017 Quality Payment Program final rule (81 FR 77178) 
that practices may receive this designation at a practice level and 
that TINs may be comprised of both undesignated practices and 
designated practices. We finalized at Sec.  414.1380(b)(3)(viii) that 
to receive full credit as a certified patient-centered medical home or 
comparable specialty practice, a TIN that is reporting must include at 
least one practice site which is a certified patient-centered medical 
home or comparable specialty practice (81 FR 77178). We also indicated 
that we would continue to have more stringent requirements in future 
years, and would lay the groundwork for expansion towards continuous 
improvement over time (81 FR 77189).
    We received many comments on the CY 2017 Quality Payment Program 
final rule regarding our transition year policy that only one practice 
site within a TIN needs to be certified as a patient-centered medical 
home for the entire TIN to receive full credit in the improvement 
activities performance category. While several commenters supported our 
transition year policy, others disagreed and suggested to move to a 
more stringent requirement in future years while still offering some 
flexibility. We refer readers to the CY 2017 Quality Payment Program 
final rule (81 FR 77180 through 77182) for the details of those 
comments and our responses. In response to these comments, in the CY 
2018 Quality Payment Program proposed rule (82 FR 30054), we proposed 
to revise Sec.  414.1380(b)(3)(x) to provide that for the 2020 MIPS 
payment year and future years, to receive full credit as a certified or 
recognized patient-centered medical home or comparable specialty 
practice, at least 50 percent of the practice sites within the TIN must 
be recognized as a patient-centered medical home or comparable 
specialty practice. This is an increase to the previously established 
requirement codified at Sec.  414.1380(b)(3) in the CY 2017 Quality 
Payment Program final rule (81 FR 77178) that only one practice site 
within a TIN needs to be certified as a patient-centered medical home. 
We chose not to propose to require that every site be certified, 
because that could potentially be overly restrictive given that some 
sites within a TIN may be in the process of being certified as patient-
centered medical homes. We believe a 50 percent threshold is 
achievable, and is supported by a study of physician-owned primary care 
groups in a recent Annals of Family Medicine article (Casalino, et al., 
2016) http://www.annfammed.org/content/14/1/16.full. For nearly all 
groups in this study (sampled with variation in size and geographic 
area), at least 50 percent of the practice sites within the group had a 
medical home designation.\2\ If the group is unable to meet the 50 
percent threshold, then the individual MIPS eligible clinician may 
choose to receive full credit as a certified patient-centered medical 
home or comparable specialty practice by reporting as an individual for 
all performance categories. In addition, we refer readers to section 
II.C.4.d. of this final rule with comment period, where we are 
finalizing to generally apply our group policies to virtual groups. 
Further, in the proposed rule, we welcomed suggestions on an 
appropriate threshold for the number of NPIs within the TIN that must 
be recognized as a certified patient-centered medical home or 
comparable specialty practice to receive full credit in the improvement 
activities performance category.
---------------------------------------------------------------------------

    \2\ Casalino LP, Chen MA, Staub CT, Press MJ, Mendelsohn JL, 
Lynch JT, Miranda Y. Large independent primary care medical groups. 
Ann Fam Med. 2016;14(1):16-25.
---------------------------------------------------------------------------

    In the CY 2018 QPP proposed rule (82 FR 30054 through 55) we 
invited public comments on our proposals to revise Sec.  
414.1380(b)(3)(x) to provide that for the 2020 MIPS payment year and 
future years, to receive full credit as a certified or recognized 
patient-centered medical home or comparable specialty practice, at 
least 50 percent of the practice sites within the TIN must be 
recognized as a patient-centered medical home or comparable specialty 
practice. However, we are correcting here that we intended to add Sec.  
414.1380(b)(3)(x) as a new provision, not revise it. This was an 
inadvertent typographical error. The following is a summary of the 
public comments received and our responses.
    Comment: Several commenters supported CMS's proposal to raise the 
threshold to 50 percent for the number of practice sites that must be 
recognized within a TIN to receive full credit in this performance 
category as a patient-centered medical home or comparable specialty. 
These commenters noted that the proposal strikes an appropriate balance 
between requiring a TIN to show substantial accomplishment before 
receiving full credit in this performance category and acknowledging 
that it may be infeasible for every practice site within a TIN to 
achieve this recognition. One commenter urged CMS to accept data feeds 
from accrediting bodies so that we can move to requiring 100 percent of 
practice sites within a TIN to achieve recognition in order to receive 
full credit in this performance category.
    Response: We appreciate the support and agree that establishing a 
50 percent threshold strikes an appropriate balance. In addition, we 
appreciate the comment regarding accepting data feeds from accrediting 
bodies and will explore this idea, including whether it is technically 
feasible, as we craft future policy.
    Comment: Another commenter supported the proposal, but suggested 
that it would be most logical to define the threshold as 50 percent of 
the primary care sites for TINs with both specialty and primary care, 
and for groups with both primary care and specialty only sites, the 
denominator for the threshold should be the number of primary care.
    Response: It is important to note that our criteria for patient-
centered medical homes include specialty sites as well, not just 
primary care. We do not believe it is appropriate to restrict patient-
centered medical home designation to primary care sites only. Based on 
a survey of patient-centered medical homes accrediting organizations, 
named in the Annals of Family Medicine article

[[Page 53653]]

2017 (Casalino, et al., 2016) cited above in our proposal, only one 
specifically requires that practices be primary care, and another 
offers specialty-specific patient-centered medical homes recognition. 
Therefore, it is reasonable to assume that specialty practices could 
attain patient-centered medical homes recognition through multiple 
accrediting organizations along with their primary care sites if they 
choose to. Overall, we believe that setting the patient-centered 
medical home group threshold at 50 percent of the group is achievable 
and it is our goal to encourage TINs to have more practice sites 
undergo transformation.
    Comment: Several commenters opposed CMS's proposal to raise the 
threshold to 50 percent for the number of practice sites that must be 
recognized within a TIN to receive full credit in this performance 
category as a patient-centered medical home or comparable specialty, 
expressing concern that it is a significant change from the first year 
of the program, and urging CMS to continue to provide flexibility in 
this area or gradually increase the threshold in future years.
    Several commenters expressed concern that the proposed threshold is 
premature and may interfere with their ability to report participation 
in an improvement activity that may be unique to their specialty group 
or discourage participation by some clinicians in the medical home 
models altogether.
    Other commenters expressed concern that CMS's proposed policy fails 
to account for the effort and investment required to achieve this 
designation, and fails to account for how the work of those sites that 
do achieve such recognition impacts specialty clinics within a TIN by 
ensuring coordinated primary care for patients as those practice sites 
refer patients needing specialized care who cannot be managed by 
primary care. Some commenters recommended that CMS consider 
alternatives to our proposal. A few commenters recommended a threshold 
of 2 or more practice sites, or beginning with a lower threshold, such 
as 33 percent. One commenter suggested that CMS instead consider 
awarding prorated credit for the entire TIN that is in proportion to 
the percentage of the TIN that is a patient-centered medical home or 
comparable specialty. For example, for one practice site that is a 
patient-centered medical home out of five sites under the same TIN, 
this practice would receive 20 percent of the 100 percent credit for 
the performance category score, and eligible clinicians in the other 
four sites within the TIN would need to demonstrate other improvement 
activities. Although MIPS eligible clinicians may choose to receive 
full credit by reporting as an individual clinician, one commenter 
noted that this is not a reasonable alternative due to the complexity 
and burden required to do so as part of a large multi-specialty group. 
This commenter suggested that before proceeding with this policy, CMS 
should determine an alternative that allows a portion of a group under 
one TIN to report as a separate subgroup on measures and activities 
that are more applicable to that subgroup. This commenter suggested 
that alternatively, CMS could incorporate thresholds into improvement 
activities, consider a variety of thresholds (for example, clinicians 
participating, target population included, entire practice included, 
etc.) and adjust the thresholds based on the type of improvement 
activity. Another commenter suggested that CMS equate this threshold 
with the credit received, giving the example that if 70 percent of NPIs 
within a TIN are performing an improvement activity, then that group 
should get 70 percent credit toward that improvement activity score. 
Commenters suggested that this addresses the possibility of a decline 
in further improvement once the set threshold is achieved.
    Response: We disagree with the commenters who oppose increasing the 
threshold to 50 percent of the group practice sites to receive patient-
centered medical home designation. Currently, only one practice site in 
a TIN with multiple practice sites is required for full credit as a 
patient-centered medical home. We recognized that the transition year 
was the first time MIPS eligible clinicians or groups would be measured 
on the quality improvement work on a national scale. Therefore, we 
approached the improvement activities performance category with these 
principles in mind along with the overarching principle for the MIPS 
program that we are building a process that will have increasingly more 
stringent requirements over time. We noted in the CY 2017 Quality 
Payment Program final rule (81 FR 77188 through 77189) that the 
baseline requirements that would continue to have more stringent 
requirements in future years, and that we were laying the groundwork 
for expansion towards continuous improvement over time. We recognized 
that quality improvement is a critical aspect of improving the health 
of individuals and the health care delivery system overall. We have 
provided great flexibility during the transition year and believe it is 
time to increase this threshold to encourage TINs to increase their 
number of patient-centered medical homes. We do not believe that only 
one MIPS eligible clinician should represent the entire group going 
forward; and accordingly, do not believe one MIPS eligible clinician's 
patient-centered medical home status should qualify the entire group to 
receive the maximum improvement activity performance category score (15 
points) toward their final score beyond the transition year. In 
addition, as discussed in our proposal above, we determined that a 50 
percent threshold would be appropriate, because we believe it is an 
achievable goal and it is supported by a study of physician-owned 
primary care groups in a recent Annals of Family Medicine article, in 
which nearly all groups of varying sizes in this study (sampled with 
variation in size and geographic area) have 50 percent or more of the 
practice sites within a group being an NCQA patient-centered medical 
home.
    In response to the commenters who believed that the proposed 
threshold may interfere with their ability to report participation in 
an improvement activity that may be unique to their specialty group, if 
those specialty groups decided to use patient-centered medical home 
recognition as their credit for the improvement activities performance 
category, those specialty groups would not be able to report on 
improvement activities unique to their specialties. We refer commenters 
to our proposal above where we state that if the group is unable to 
meet the 50 percent threshold, then the individual MIPS eligible 
clinicians may choose to receive full credit as a recognized or 
certified patient-centered medical home, or comparable specialty 
practice, as an individual for all performance categories (82 FR 
30054). To emphasize this point, specialty clinicians could either be 
recognized as a comparable specialty practice under the patient-
centered medical home designation, which would reflect the specialty 
care they provide, or they could report on improvement activities that 
may be unique to their specialty group as individual reporters. 
Therefore, we do not believe that setting the patient-centered medical 
home threshold at 50 percent would interfere with a group's ability to 
report other specialty specific improvement activities. We believe that 
the suggestion that we use a threshold of 2 or more practice sites, 
instead of 50 percent might discourage large medical groups from 
investing in patient-centered medical home transformation more broadly, 
because many large

[[Page 53654]]

medical groups may have ten practice sites, and having only 2 sites 
recognized as patient-centered medical homes would mean a very 
different investment for a practice with 3 sites than it would for a 
practice with 30 sites. We also disagree that a threshold of 33 percent 
is appropriate, because the literature (Casalino, et al., 2016), as 
cited in our proposal, demonstrated that a 50 percent target is 
achievable and we have seen a subset of large, multi-specialty medical 
groups from across the country that have already surpassed this target. 
We also believe that finalizing a proportion lower than 50 percent of 
practice sites would unfairly discredit practices that have greater 
integration and required a significant investment. In addition, using a 
pro-rated approach as suggested by a commenter brings significant added 
complexity and burden, for which we do not believe outweighs the 
benefits.
    Comment: Several commenters indicated that large multispecialty 
practices, such as academic medical centers, have a large number of 
specialists; therefore, it is unlikely that 50 percent of the practice 
sites under their TIN would be recognized as medical homes. Commenters 
cautioned that excluding these medical homes from getting credit while 
other practices get full credit is likely to discourage practice 
locations from seeking this designation.
    Response: Regarding commenters who suggested that large 
multispecialty practices, such as academic medical centers with a large 
number of specialists would be unlikely to have 50 percent of the 
practice sites under their TIN recognized as medical homes, we want to 
raise the threshold to encourage greater transition such that there a 
meaningful investment in transforming their practice sites. Having 50 
percent of their sites being recognized as patient-centered medical 
homes represents a significant investment toward practice 
transformation that is achievable and supported by the literature. As 
cited in our proposal (Casalino, et al., 2016), studies have 
demonstrated that a 50 percent target is achievable and we have seen a 
subset of large, multi-specialty medical groups from across the country 
that have already surpassed this target. In addition, if an academic 
medical center has numerous sites, and only one is a patient-centered 
medical home, we do not believe that represent the same degree of 
investment in practice transformation as a TIN with 50 percent or more 
of the practice sites being recognized medical homes, because because 
having only 2 sites recognized as patient-centered medical homes would 
mean a very different investment for a practice with 3 sites than it 
would for a practice with 30 sites.
    Comment: Another commenter suggested that CMS use the CMS Study on 
Burden Associated with Quality Reporting that is discussed in section 
II.C.6.e.(9) of this final rule with comment period to solicit input 
from stakeholders about how to assess thresholds of participation, 
score practices on performance, and assess improvement.
    Response: As discussed in the CY 2017 Quality Payment Program final 
rule (81 FR 77195) the CMS Study on Burden Associated with Quality 
Reporting goals are to see whether there will be improved outcomes, 
reduced burden in reporting, and enhancements in clinical care by 
selected MIPS eligible clinicians desiring:
     A more data driven approach to quality measurement.
     Measure selection unconstrained by a CEHRT program or 
system.
     Improving data quality submitted to CMS.
     Enabling CMS get data more frequently and provide feedback 
more often.
    We do not believe the CMS Study on Burden Associated with Quality 
Reporting is the appropriate vehicle to assess thresholds of 
participation, score practices on performance, and assess improvement. 
We will, however, take these comments into consideration as we craft 
future policies.
    Comment: One commenter requested that CMS more clearly define the 
term ``practice'' used in the CY 2018 Quality Payment proposed rule (82 
FR 30054) and clarify, for example, whether ``practice'' means a 
physical location where services are delivered or the administrative 
address, among other things, and urged CMS to define this term in a way 
that includes as many individual MIPS eligible clinicians as possible.
    Response: In the CY 2018 Quality Payment Program proposed rule (82 
FR 30054), we proposed to revise Sec.  414.1380(b)(3)(x) to provide 
that for the 2020 MIPS payment year and future years, to receive full 
credit as a certified or recognized patient-centered medical home or 
comparable specialty practice, at least 50 percent of the practice 
sites within the TIN must be recognized as a patient-centered medical 
home or comparable specialty practice. However, we note again that we 
intended to add Sec.  414.1380(b)(3)(x) as a new provision, not revise 
it. This was an inadvertent typographical error. We interpret commenter 
to be referring to our use of the term ``practice sites'' and we agree 
with the commenter that defining this term will reduce ambiguity. In 
response, we are clarifying in this final rule that a practice site is 
the physical location where services are delivered. We are 
operationalizing this definition by using the practice address field 
within the Provider Enrollment, Chain and Ownership System (PECOS). We 
believe this definition is generally acceptable in the medical 
community as a whole, because physical practice locations are a common 
way for primary care to be organized.
    Comment: One commenter stated that the intent of MACRA was to give 
all practices recognized as a patient-centered medical home or 
comparable specialty full credit in the improvement activities 
performance category and that the proposed threshold is not consistent 
with the intent of Congress.
    Response: We disagree with the commenter that our proposal is 
contrary to the intent of Congress. Section 1848(q)(5)(C)(i) of the Act 
specifies that a MIPS eligible clinician or group that is certified or 
recognized as a patient-centered medical home or comparable specialty 
practice, as determined by the Secretary, must be given the highest 
potential score for the improvement activities performance category for 
the performance period. We believe the statute gives the Secretary 
discretion to determine what qualifies as a certified or recognized 
patient-centered medical home or comparable specialty practice. We have 
provided the utmost flexibility by allowing any undesignated practices 
to receive full credit simply by virtue of being in a TIN with one 
designated practice. As discussed in the CY 2017 Quality Payment 
Program final rule (81 FR 30054) for the transition year, that 
practices may receive a patient-centered medical home designation at a 
practice level, and that individual TINs may be composed of both 
undesignated practices and practices that have received a designation 
as a patient-centered medical home (for example, only one practice site 
has received patient-centered medical home designation in a TIN that 
includes five practice sites). In addition, we finalized an expanded 
definition of what is acceptable for recognition as a certified 
patient-centered medical home or comparable specialty practice (81 FR 
77180). We refer readers to Sec.  414.1380(3)(iv) for details. We 
recognized a MIPS eligible clinician or group as being a certified 
patient-centered medical home or comparable specialty practice if they 
have achieved certification or accreditation as such from a national 
program, or they have achieved certification or accreditation as

[[Page 53655]]

such from a regional or state program, private payer or other body that 
certifies at least 500 or more practices for patient-centered medical 
home accreditation or comparable specialty practice certification (81 
FR 77180). Examples of nationally recognized accredited patient-
centered medical homes are: (1) The Accreditation Association for 
Ambulatory Health Care; (2) the National Committee for Quality 
Assurance (NCQA) Patient-Centered Medical Home; (3) The Joint 
Commission Designation; or (4) the Utilization Review Accreditation 
Commission (URAC) (81 FR 77180). We finalized that the criteria for 
being a nationally recognized accredited patient-centered medical home 
are that it must be national in scope and must have evidence of being 
used by a large number of medical organizations as the model for their 
patient-centered medical home (81 FR 77180). We also provided full 
credit for the improvement activities performance category for a MIPS 
eligible clinician or group that has received certification or 
accreditation as a patient-centered medical home or comparable 
specialty practice from a national program or from a regional or state 
program, private payer or other body that administers patient-centered 
medical home accreditation and certifies 500 or more practices for 
patient-centered medical home accreditation or comparable specialty 
practice certification (81 FR 77180). Once a MIPS eligible clinician or 
group is certified or recognized as a patient-centered medical home or 
comparable specialty practice, those clinicians or groups are given the 
full improvement activities score (for example, 40 points) (81 FR 
77180). This policy specifically applies to MIPS eligible groups; 
individual MIPS eligible clinicians may still attest that their 
practice is part of a patient-centered medical home or comparable 
specialty practice as established for the transition year in the CY 
2017 Quality Payment Program final rule (81 FR 77189).
    Final Action: After consideration of the public comments received, 
we are finalizing our proposals with clarification. Specifically, we 
are finalizing that for the 2020 MIPS payment year and future years, to 
receive full credit as a certified or recognized patient-centered 
medical home or comparable specialty practice, at least 50 percent of 
the practice sites within the TIN must be recognized as a patient-
centered medical home or comparable specialty practice. We are 
clarifying that a practice site as is the physical location where 
services are delivered. We are also finalizing to add Sec.  
414.1380(b)(3)(x) to reflect these changes.
(A) CPC+
    In the CY 2018 Quality Payment Program proposed rule (82 FR 30054) 
we stated that we have determined that the Comprehensive Primary Care 
Plus (CPC+) APM design satisfies the requirements to be designated as a 
medical home model, as defined in Sec.  414.1305; and therefore, as 
defined at 81 FR 77178 that states that patient-centered medical homes 
will be recognized if it is a nationally recognized accredited patient-
centered medical home, a Medicaid Medical Home Model, or a Medical Home 
Model, CPC+ APM is also a certified or recognized patient-centered 
medical home for purposes of the improvement activities performance 
category. We have also determined that the CPC+ APM meets the criteria 
to be an Advanced APM. We refer readers to https://qpp.cms.gov/docs/QPP_Advanced_APMs_in_2017.pdf for more information. Participating CPC+ 
practices in the Model must adopt, at a minimum, the certified health 
IT needed to meet the certified EHR technology (CEHRT) definition at 
Sec.  414.1305. In addition, participating CPC+ practices receive 
payments for covered professional services based on quality measures 
comparable to those used in the quality performance category of MIPS, 
and they bear more than a nominal amount of financial risk for monetary 
losses as described at Sec.  414.1415.
    We recognized the possibility that certain practices that applied 
to participate in Round 2 of the CPC+ APM, but were not chosen to 
participate in the model, could potentially be randomized into a CPC+ 
control group. The control group practices would meet all of the same 
eligibility requirements as the CPC+ participating practices (also 
known as the ``intervention group'') but the control group would not 
``participate'' in the APM (for example, undertake the CPC+ care 
delivery activities such as providing 24/7 clinician access, or empanel 
attributed Medicare beneficiaries) or receive any of the CPC+ payments. 
In the CY 2018 Quality Payment Program proposed rule (82 FR 30015), we 
discussed that we believe MIPS eligible clinicians, who are 
participating in the CPC+ APM, whether actively in the intervention 
group or as part of the control group, should therefore receive full 
credit for the improvement activities performance category.
    Accordingly, in the CY 2018 Quality Payment Program proposed rule 
(82 FR 30054 through 30055), we proposed that MIPS eligible clinicians 
in practices randomized to the control group in the CPC+ APM would 
receive full credit as a medical home model, and therefore, a certified 
patient-centered medical home, for the improvement activities 
performance category. In other words, MIPS eligible clinicians who 
attest that they are in practices that have been randomized to the 
control group in the CPC+ APM would receive full credit for the 
improvement activities performance category for each performance period 
in which they are on the Practitioner Roster, the official list of 
eligible clinicians participating in a practice in the CPC+ control 
group (82 FR 30054 through 30055).
    We invited public comment on our proposal. The following is a 
summary of public comments received on this proposal and our response.
    Comment: Several commenters stated that they support recognizing 
CPC+ control group participants as participating in a medical home 
model and receiving full credit for the improvement activities 
performance category. The commenters noted that the focus of these 
practices should be on developing a balance in primary care and 
specialty care focused high-weight improvement activities. One 
commenter stated that the requirements of CPC+ are such that there 
would be a guarantee that participants are carrying out true practice 
improvement activities focused on patient-centered care.
    Response: We thank commenters for their support. As an update, CMS 
has not randomized any practices that will begin participation in CPC+ 
in 2018 into a control group. Because we have not randomized any 
practices into a control group in CPC+ Round 2, we are not finalizing 
our proposal.
    Final Action: After consideration of the public comments we 
received and developments in the CPC+ Model, we are not finalizing our 
proposal as discussed above.
(c) Required Period of Time for Performing an Activity
    In the CY 2017 Quality Payment Program final rule (81 FR 77186), we 
specified at Sec.  414.1360 that MIPS eligible clinicians or groups 
must perform improvement activities for at least 90 consecutive days 
during the performance period for improvement activities performance 
category credit. Activities, where applicable, may be continuing (that 
is, could have started prior to the performance period and are 
continuing) or be adopted in the

[[Page 53656]]

performance period as long as an activity is being performed for at 
least 90 days during the performance period. In the CY 2018 Quality 
Payment Program proposed rule (82 FR 30055), we did not propose any 
changes to the required period of time for performing an activity for 
the improvement activities performance category in the proposed rule. 
We also refer readers to section II.C.4.d. of this final rule with 
comment period, where we are finalizing to generally apply our group 
policies to virtual groups.
    We received many comments on this topic and will take them into 
consideration for future rulemaking.
(4) Application of Improvement Activities to Non-Patient Facing 
Individual MIPS Eligible Clinicians and Groups
    In the CY 2017 Quality Payment Program final rule (81 FR 77187), we 
specified at Sec.  414.1380(b)(3)(vii) that for non-patient facing 
individual MIPS eligible clinicians or groups, to achieve the highest 
score one high-weighted or two medium-weighted improvement activities 
are required. For these individual MIPS eligible clinicians and groups, 
in order to achieve one-half of the highest score, one medium-weighted 
improvement activity is required (81 FR 77187). In the CY 2018 Quality 
Payment Program proposed rule (82 FR 30055), we did not propose any 
changes to the application of improvement activities to non-patient 
facing individual MIPS eligible clinicians and groups for the 
improvement activities performance category.
    We received a few comments on this topic and will take them into 
consideration for future rulemaking.
(5) Special Consideration for Small, Rural, or Health Professional 
Shortage Areas Practices
    In the CY 2017 Quality Payment Program final rule (81 FR 77188), we 
finalized at Sec.  414.1380(b)(3)(vii) that one high-weighted or two 
medium-weighted improvement activities are required for individual MIPS 
eligible clinicians and groups that are small practices or located in 
rural areas, or geographic HPSAs, to achieve full credit. In addition, 
we specified at Sec.  414.1305 that a rural area means ZIP codes 
designated as rural, using the most recent HRSA Area Health Resource 
File data set available (81 FR 77012). Lastly, in the CY 2017 Quality 
Payment Program final rule (81 FR 77539 through 77540), we codified the 
following definitions at Sec.  414.1305: (1) Small practices is defined 
to mean practices consisting of 15 or eligible clinicians; and (2) 
Health Professional Shortage Areas (HPSA) refers to areas as designated 
under section 332(a)(1)(A) of the Public Health Service Act. In the CY 
2018 Quality Payment Program proposed rule (82 FR 30055), we did not 
propose any changes to the special consideration for small, rural, or 
health professional shortage areas practices for the improvement 
activities performance category in the proposed rule.
    We received many comments on this topic and will take them into 
consideration for future rulemaking.
(6) Improvement Activities Subcategories
    In the CY 2017 Quality Payment Program final rule (81 FR 77190), we 
finalized at Sec.  414.1365 that the improvement activities performance 
category will include the subcategories of activities provided at 
section 1848(q)(2)(B)(iii) of the Act. In addition, we finalized (81 FR 
77190) at Sec.  414.1365 the following additional subcategories: 
Achieving Health Equity; Integrated Behavioral and Mental Health; and 
Emergency Preparedness and Response. In the CY 2018 Quality Payment 
Program proposed rule (82 FR 30055), we did not propose any changes to 
the improvement activities subcategories for the improvement activities 
performance category in the proposed rule.
    We received a few comments on this topic and will take them into 
consideration for future rulemaking.
(7) Improvement Activities Inventory
    We refer readers to Table H in the Appendix of the CY 2017 Quality 
Payment Program final rule (81 FR 77817) for our previously finalized 
Improvement Activities Inventory for the transition year of MIPS and 
future years. In this final rule with comment period, we are finalizing 
updates to the Improvement Activities Inventory, formalizing the 
process for adding new improvement activities to the Improvement 
Activities Inventory, and finalizing the criteria for nominating new 
improvement activities. These are discussed in detail below.
(a) Annual Call for Activities Process for Adding New Activities
(i) Transition Year
    As discussed in the CY 2017 Quality Payment Program final rule (81 
FR 77190), for the transition year of MIPS, we implemented the initial 
Improvement Activities Inventory and took several steps to ensure it 
was inclusive of activities in line with statutory and program 
requirements. Prior to selecting the improvement activities, we 
conducted background research. We interviewed high performing 
organizations of all sizes, conducted an environmental scan to identify 
existing models, activities, or measures that met all or part of the 
improvement activities performance category requirements, including the 
patient-centered medical homes, the Transforming Clinical Practice 
Initiative (TCPI), CAHPS surveys, and AHRQ's Patient Safety 
Organizations (81 FR 77190). In addition, we reviewed comments from the 
CY 2016 PFS final rule with comment period (80 FR 70886), and those 
received in response to the MIPS and APMs RFI published in the October 
1, 2015 Federal Register (80 FR 59102, 59106 through 59107) regarding 
the improvement activities performance category. The Improvement 
Activities Inventory finalized in the CY 2017 Quality Payment Program 
final rule (81 FR 77817 through 77831) in Table H of the Appendix, for 
the transition year and future years, was compiled as a result of the 
stakeholder input, an environmental scan, the MIPS and APMs RFI 
comments, and subsequent working sessions with AHRQ and ONC and 
additional communications with CDC, SAMHSA, and HRSA.
(ii) Year 2
    For the Quality Payment Program Year 2, we provided an informal 
process for submitting new improvement activities for potential 
inclusion in the comprehensive Improvement Activities Inventory for the 
Quality Payment Program Year 2 and future years through subregulatory 
guidance (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/Annual-Call-for-Measures-and-Activities-for-MIPS_Overview-Factsheet.pdf). As part of this informal 
process, we solicited and received input from various MIPS eligible 
clinicians and organizations suggesting possible new activities via a 
nomination form that was posted on the CMS Web site at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/CallForMeasures.html. These nominations were 
vetted by an internal CMS review panel that conferred with other 
federal partners. New activities or modifications to existing 
activities were proposed in the CY 2018 Quality Payment Program 
proposed rule (82 FR 30479 through 30500) Improvement Activities 
Inventory in Tables F and G of the Appendix for Year 2 of the MIPS 
program. We refer readers to the CY 2017 Quality Payment Program final 
rule (81 FR 77817 through 77831) in

[[Page 53657]]

Table H of the Appendix, for the transition year and future years and 
Tables F and G of the Appendix of this final rule with comment period 
for our finalized Improvement Activities Inventory for Year 2 and 
future years of MIPS.
(iii) Year 3 and Future Years
    For the Quality Payment Program Year 3 and future years, in the CY 
2018 Quality Payment Program proposed rule (82 FR 30055), we proposed 
to formalize an Annual Call for Activities process for adding possible 
new activities or providing modifications to the current activities in 
the Improvement Activities Inventory. We believe this is a way to 
engage eligible clinician organizations and other relevant 
stakeholders, including beneficiaries, in the identification and 
submission of improvement activities for consideration. Specifically, 
we proposed that individual MIPS eligible clinicians or groups and 
other relevant stakeholders may recommend activities for potential 
inclusion in the Improvement Activities Inventory via a similar 
nomination form that was utilized in the Year 2 of MIPS informal Annual 
Call for Activities found on the Quality Payment Program Web site at 
www.qpp.cms.gov, as discussed above. As part of this formalized 
process, individual MIPS eligible clinicians, groups, and other 
relevant stakeholders would be able to nominate new improvement 
activities that we may consider adding to the Improvement Activities 
Inventory. Individual MIPS eligible clinicians and groups and relevant 
stakeholders would be required to provide an explanation, via the 
nomination form, of how the improvement activity meets all the relevant 
criteria proposed in the CY 2018 Quality Payment Program proposed rule 
(82 FR 30055 through 30056) and finalized below in section 
II.C.6.e.(7)(b) of this final rule with comment period.
    We refer readers to the Improvement Activities Inventory in Tables 
F and G of the Appendix of this final rule with comment period where we 
are finalizing new activities and changes to existing activities, some 
with modification. We invited public comment on our proposal to 
formalize the Annual Call for Activities process for the Quality 
Payment Program Year 3 and future years.
    Comment: Several commenters supported the proposal to formalize an 
Annual Call for Activities process to facilitate the solicitation of 
new improvement activities. The commenters supported CMS's criteria for 
improvement activities that continue to follow the priorities of the 
National Quality Strategy. In addition, other commenters noted that the 
addition of new improvement activities creates more opportunity for 
clinicians to select a suite of activities that further a particular 
improvement goal, rather than choosing several discrete activities, 
which together may not move the practice toward transformation. Several 
commenters supported the inclusion of improvement activities that 
demonstrate the delivery of patient and family centered care.
    Response: We thank the commenters for their support.
    Comment: One commenter suggested that quality and practice 
transformation standards such as the National Committee for Quality 
Assurance (NCQA) patient-centered medical home recognition should be 
the basis for reporting and validating improvement activities.
    Response: We are considering the standards for reporting and 
validation, given that each national accrediting organization has 
different reporting requirements and utilizes different standards to 
evaluate their respective patient-centered medical home recognition 
programs. Although the AHRQ patient-centered medical home definition 
(https://pcmh.ahrq.gov/page/defining-pcmh) identified national 
accrediting organizations' patient-centered medical home models which 
align around recognized functions, their standards and activities for 
evaluation of each element may be different. Likewise, the data 
collected and maintained by each accrediting organization may be 
updated during different time frames and assess or evaluate performance 
elements using different methodologies, presenting challenges to 
standardizing validation that would need to be addressed through 
further research. We are evaluating the technical feasibility of having 
an external entity report and potentially validate improvement 
activities in the future. We refer readers to the Quality Payment 
Program Web site Resource Library at https://qpp.cms.gov/ (MIPS Data 
Validation Criteria), which provides the current expected data 
validation information.
    Comment: Some commenters also encouraged CMS to ensure that 
accepted improvement activities are aligned with measures for the other 
performance categories.
    Response: We agree that it is important to create a program in 
which the performance categories are aligned as much as possible. We 
will continue to identify those improvement activities that are also 
eligible for the advancing care information performance category in the 
Improvement Activities Inventory. We encourage stakeholders to submit 
new improvement activities and modifications to existing improvement 
activities that help to align performance categories through the Annual 
Call for Activities.
    Comment: Commenters also encouraged CMS to ensure that the process 
is transparent, urged CMS to continue to be flexible and include as 
many proposed improvement activities on the final list as possible, and 
urged CMS to create more explicit inclusion criteria, which would 
further streamline the process of hospitals identifying the broader 
activity to which the discrete activity belongs. A few commenters 
expressed concern that improvement activities that were submitted were 
not accepted and urged CMS to be more transparent in the manner in 
which they make decisions about: (1) Which improvement activities are 
included and not included in the inventory, and (2) the weighting of 
improvement activities. In addition, they urged CMS to provide 
additional rationale to submitters when their recommended improvement 
activities are not accepted and engage specialists and non-specialists 
equally to select improvement activities for inclusion in the 
Inventory.
    Response: As we have developed the Improvement Activity Inventory, 
we have strived to be flexible and have accepted as many improvement 
activities as possible that are appropriate. As we work to further 
develop the Annual Call for Activities process, we intend to be as 
transparent as feasible. In the CY 2017 Quality Payment final rule (81 
FR 77190), we discussed some guidelines by which improvement activities 
are selected based on a set of criteria. We note that the Annual Call 
for Activities that was held in Year 2 for improvement activities that 
will be applicable for the 2018 performance period, was an informal 
process. We formally proposed criteria in the CY 2018 QPP proposed rule 
(82 FR 30055 through 30056) and are finalizing them in section 
II.C.6.e.(7)(b) of this final rule with comment period. We refer 
readers to section II.C.6.e.(7)(b) of this final rule with comment 
period.
    We will take the commenters' feedback into consideration as we work 
to refine the Annual Call for Activities process for future years.
    Comment: Another commenter recommended that CMS prioritize 
additional modifications to existing improvement activities and adopt 
new

[[Page 53658]]

improvement activities on a more gradual basis.
    Response: We do not disagree that we should prioritize 
modifications to the current improvement activities over new 
improvement activities as we believe they are both valuable. We must 
balance burden with including a sufficient number and variety of 
improvement activities in the Inventory so that all MIPS eligible 
clinician and groups have relevant activities to select. However, we 
are mindful of adopting new activities gradually; the Improvement 
Activities Inventory has not grown by more than 20 percent for the 2018 
performance period.
    Comment: Several commenters supported the addition of improvement 
activities for hospitals, but recommended that CMS work with partners, 
clinicians, researchers, and other stakeholders to develop a broad set 
of activities to fill existing gaps in the program. Some commenters 
expressed concern that the Inventory is too heavily focused on primary 
care and urged us to work closely with specialty societies to solicit 
and develop additional improvement activities.
    Response: We consistently engage a variety of groups within 
different specialties via webinars and listening sessions to get 
improvement activity feedback. We do not agree that the Improvement 
Activities Inventory is primary care focused as there are many 
activities specialists may perform. As discussed in the CY 2017 Quality 
Payment Program final rule (82 FR 77190), we wanted to create a broad 
list of activities that can be used by multiple practice types to 
demonstrate improvement activities and activities that may lend 
themselves to being measured for improvement in future years. We took 
several steps to ensure the initial improvement activities inventory is 
inclusive of activities in line with the statutory language. We had 
numerous interviews with highly performing organizations of all sizes, 
conducted an environmental scan to identify existing models, 
activities, or measures that met all or part of the improvement 
activities performance category. We also encourage specialties to 
submit new improvement activities and modifications to existing 
improvement activities through the Annual Call for Activities.
    Comment: Several commenters noted that it would make more sense to 
reorganize and augment the Improvement Activities Inventory to align 
explicitly with the requirements in MIPS, and for APMs. Several 
commenters believed that improvement activities should be developed and 
added that would support a practice's capacity to analyze its own 
quality data and be prepared to share downside risk in order to 
participate in an APM. The commenters encouraged CMS to align the 
thresholds and reporting requirements across performance categories for 
any of these overlapping activities, in order to reduce burden.
    Response: Section 1848(q)(2)(B)(iii) of the Act specified 
subcategories improvement activities. However, we are working to ensure 
that improvement activities align across the performance categories and 
must balance burden with including a sufficient number and variety of 
improvement activities in the Inventory so that all MIPS eligible 
clinician and groups have relevant activities to select, and in 
particular for clinicians who do not participate in APMs as we do not 
want to the Inventory to be exclusive to any one group. We encourage 
stakeholders to submit new improvement activities and modifications to 
existing improvement activities through the Annual Call for Activities.
    Comment: One commenter encouraged CMS to specify improvement 
activities for which a participant can use application programming 
interfaces (APIs) to receive another advancing care information bonus 
point. The commenter noted that doing so would further incentivize 
clinicians to utilize the API functionality for health information 
sharing with beneficiaries as part of patient engagement and care 
coordination activities.
    Response: We will take the commenter's suggestions for specifying 
improvement activities that are eligible for a bonus in the advancing 
care information performance category into consideration in future 
rulemaking. We note that in the CY 2017 Quality Payment Program final 
rule (81 FR 77182), we finalized a policy to allow MIPS eligible 
clinicians to achieve a bonus in the advancing care information 
performance category when they use functions included in CEHRT to 
complete eligible activities from the improvement activities inventory, 
and codified at Sec.  414.1380 that we would provide a designation 
indicating which activities qualify for the advancing care information 
bonus finalized. In addition, we refer readers to section II.E.5.g. of 
this final rule with comment period for details on how improvement 
activities using CEHRT relate to the objectives and measures of the 
advancing care information and improvement activities performance 
categories. We acknowledge the commenters additional suggestions and 
note that in addition to those functions included under the CEHRT 
definition, we advised in the CY 2017 Quality Payment Program final 
rule (81 FR 77199) that we may consider including additional ONC 
certified health IT capabilities as part of activities within the 
improvement activities inventory in future years. However, we are not 
making any changes to our current approach for allowing MIPS eligible 
clinicians to achieve a bonus in the advancing care performance 
category in this final rule with comment period.
    Comment: Some commenters encouraged CMS to consider the role of 
digital technologies in improving care and including related activities 
as part of continual improvement activities for future consideration. 
Some commenters supported the inclusion of telehealth-related 
improvement activities in the Inventory and suggested that these be 
high-weighted activities. A few commenters recommended that improvement 
activities that are registry-focused be assigned a high-weight, or 
alternatively, that CMS allow eligible clinicians who participate in a 
registry and meet certain basic requirements to receive the maximum 
score in this performance category.
    Response: We acknowledge commenters' suggestions for considering 
digital technologies and telehealth in improvement activities and their 
weighting in the Improvement Activities Inventory. We note that we have 
reserved high weighting for activities that directly address areas with 
the greatest impact on beneficiary care, safety, health, and well-
being, as explained in the CY 2017 Quality Payment Program final rule 
(81 FR 77194). We are not making any changes to this approach in this 
final rule with comment period; however, we will take these commenters' 
suggestions into consideration for future rulemaking. We also encourage 
stakeholders to submit activities for consideration during our formal 
Annual Call for Activities finalized in this final rule with comment 
period, as suggestions regarding improvement activity type, and content 
will be taken into consideration as part of that process. Finally, we 
do not agree that clinicians who participate in a registry and meet 
certain basic requirements should receive the maximum improvement 
activities score at this time, as we do not have sufficient data to 
determine what basic requirements might be sufficient to merit full 
credit, or what impact such an approach would have across MIPS eligible 
clinicians and groups.
    Comment: One commenter noted that some of the proposed activities 
exclude

[[Page 53659]]

clinicians who are not physicians from participation, and advised us to 
be mindful of this going forward.
    Response: We believe that this comprehensive Improvement Activities 
Inventory includes a broad range of activities that can be used by 
multiple clinician and practice types to demonstrate improvement 
activities and activities that may lend themselves to being measured 
for improvement in future years. We will take this concern into 
consideration, however, as we craft future policy, and we encourage 
stakeholders to submit new activities or suggestions for modifications 
to existing activities for consideration during our Annual Call for 
Activities.
    Comment: One commenter urged CMS to accept input from stakeholders 
regarding the weighting of several activities already included in the 
inventory that are resource intensive and currently have a medium 
weighting, and reconsider the weighting of these activities.
    Response: We refer the commenter and readers to Tables F and G in 
the Appendices of this final rule with comment period where we received 
public input on the weighting of a number of existing improvement 
activities. We previously stated that we believe high weighting should 
be used for activities that directly address areas with the greatest 
impact on beneficiary care, safety, health, and well-being, as 
explained in the CY 2017 Quality Payment Program final rule (81 FR 
77194). While we are not making any changes to this approach in this 
final rule with comment period, we will take the commenter's 
suggestions into consideration for future rulemaking. We also encourage 
commenter to submit new improvement activities, or recommendations for 
modifications to existing activities (including weighting) to us for 
consideration during the Annual Call for Activities.
    Comment: Several commenters proposed additional concepts for 
improvement activities for the Quality Payment Program Year 2, 
including improvement activities that address participation in self-
assessment or ongoing learning activities; improving access to care; 
engaging patients and families in practice governance; using telehealth 
for patient interactions; and collaborating and data-sharing with 
Regional Health Improvement Networks. Several comments were received 
requesting various new improvement activities for inclusion in the 
Improvement Activities Inventory.
    Response: We thank the commenters for their suggestions. While the 
informal process for the nominating improvement activities for MIPS 
Year 2 is now closed, we encourage stakeholders to submit new 
improvement activities and modifications to existing improvement 
activities through the upcoming Annual Call for Activities.
    Final Action: After consideration of the public comments we 
received, we are finalizing our proposal, as proposed, to formalize the 
Annual Call for Activities process for Quality Payment Program Year 3 
and future years, as discussed in this final rule with comment period.
(b) Criteria for Nominating New Improvement Activities for the Annual 
Call for Activities
    In the CY 2017 Quality Payment final rule (81 FR 77190), we 
discussed guidelines for the selection of improvement activities. In 
the CY 2018 Quality Payment Program proposed rule (82 FR 30055 and 
30485), we formally proposed that for the Quality Payment Program Year 
3 and future years, that stakeholders would apply one or more of the 
following criteria when submitting improvement activities in response 
to the proposed formal Annual Call for Activities. We intend to also 
use these criteria in selecting improvement activities for inclusion in 
the program.
     Relevance to an existing improvement activities 
subcategory (or a proposed new subcategory);
     Importance of an activity toward achieving improved 
beneficiary health outcome;
     Importance of an activity that could lead to improvement 
in practice to reduce health care disparities;
     Aligned with patient-centered medical homes;
     Activities that may be considered for an advancing care 
information bonus;
     Representative of activities that multiple individual MIPS 
eligible clinicians or groups could perform (for example, primary care, 
specialty care);
     Feasible to implement, recognizing importance in 
minimizing burden, especially for small practices, practices in rural 
areas, or in areas designated as geographic HPSAs by HRSA;
     Evidence supports that an activity has a high probability 
of contributing to improved beneficiary health outcomes; or
     CMS is able to validate the activity.
    We also noted in our proposal that in future rulemaking, activities 
that overlap with other performance categories may be proposed to be 
included if such activities support the key goals of the program.
    We invited public comment on our proposal. The following is a 
summary of the public comments received on the ``Criteria for 
Nominating New Improvement Activities for the Annual Call for 
Activities'' proposals and our responses.
    Comment: Several commenters provided suggested additional selection 
criteria: (1) Improvement activities should focus on meaningful 
activities from the person and family's point of view, not structural 
processes that do not improve clinical care; and (2) there should be 
consideration for adding new activities that focus on identifying and 
supporting the patient's family or personal caregiver. A few commenters 
requested that CMS expand the definition of eligible activities to 
include ``actions that reduce barriers to care,'' and to include 
interpretation and transportation services explicitly.
    Response: We acknowledge commenters' suggestions for additional 
criteria, and in response to these comments, we are expanding the 
proposed criteria to also include: (1) Improvement activities that 
focus on meaningful actions from the person and family's point of view; 
and (2) improvement activities that support the patient's family or 
personal caregiver. We believe these are appropriate to add, because 
they closely align with one of our MIPS strategic goals, to use a 
patient-centered approach to program development that leads to better, 
smarter, and healthier care.
    In addition, we currently include several activities in the 
Improvement Activities Inventory that address barriers to care, such as 
IA_CC_16, Primary Care Physician and Behavioral Health Bilateral 
Electronic Exchange of Information for Shared Patients, which rewards 
primary care and behavioral health practices using the same electronic 
health record system for shared patients or for exchanging information 
bilaterally and IA_PM_18 Provide Clinical-Community Linkages, which 
rewards MIPS eligible clinicians engaging community health workers to 
provide a comprehensive link to community resources through family-
based services focusing on success in health, education, and self-
sufficiency. However, we will consider criteria that address ``actions 
that reduce barriers to care'' and those that identify interpretation 
and transportation services as we craft future policies.
    Final Action: After consideration of the public comments received, 
we are finalizing with modification, for the Quality Payment Program 
Year 3 and future years, that stakeholders should apply one or more of 
the criteria when

[[Page 53660]]

submitting improvement activities in response to the Annual Call for 
Activities. In addition to the criteria listed in the proposed rule for 
nominating new improvement activities for the Annual Call for 
Activities policy we are modifying and expanding the proposed criteria 
list to also include: (1) Improvement activities that focus on 
meaningful actions from the person and family's point of view, and (2) 
improvement activities that support the patient's family or personal 
caregiver. The finalized list of criteria for submitting improvement 
activities in response to the Annual Call for Activities is as follows:
     Relevance to an existing improvement activities 
subcategory (or a proposed new subcategory);
     Importance of an activity toward achieving improved 
beneficiary health outcome;
     Importance of an activity that could lead to improvement 
in practice to reduce health care disparities;
     Aligned with patient-centered medical homes;
     Focus on meaningful actions from the person and family's 
point of view;
     Support the patient's family or personal caregiver;
     Activities that may be considered for an advancing care 
information bonus;
     Representative of activities that multiple individual MIPS 
eligible clinicians or groups could perform (for example, primary care, 
specialty care);
     Feasible to implement, recognizing importance in 
minimizing burden, especially for small practices, practices in rural 
areas, or in areas designated as geographic HPSAs by HRSA;
     Evidence supports that an activity has a high probability 
of contributing to improved beneficiary health outcomes; or
     CMS is able to validate the activity.
(c) Submission Timeline for Nominating New Improvement Activities for 
the Annual Call for Activities
    During the informal process, we accepted nominations from February 
16 through Febuary 28, 2017. For the Quality Payment Program Year 2, we 
provided an informal process for submitting new improvement activities 
for potential inclusion in the comprehensive Improvement Activities 
Inventory for the Quality Payment Program Year 2 and future years 
through subregulatory guidance (https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/Annual-Call-for-Measures-and-Activities-for-MIPS_Overview-Factsheet.pdf). As part 
of this informal process, we solicited and received input from various 
MIPS eligible clinicians and organizations suggesting possible new 
activities via a nomination form that was posted on the CMS Web site at 
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/MMS/Downloads/CallForMeasures.html.
    It is our intention that the nomination and acceptance process for 
improvement activities, to the best extent possible, parallel the 
Annual Call for Measures process that is already conducted for MIPS 
quality measures. We refer readers to the CY 2017 Quality Payment 
Program final rule (81 FR 77147 through 77153) and section II.C.6.c.(1) 
of this final rule with comment period for more information. Therefore, 
aligned with this process, in the CY 2018 Quality Payment Program 
proposed rule (82 FR 30056), we proposed to accept submissions for 
prospective improvement activities at any time during the performance 
period for the Annual Call for Activities and create an Improvement 
Activities Under Review (IAUR) list which will be displayed on a CMS 
Web site. For example, the CY 2019 performance period spans January 1, 
2019 through December 31, 2019, therefore, the submission period for CY 
2019 prospective improvement activities would be March 2, 2017 through 
March 1, 2018. When submissions are received after the March 1 deadline 
then that submission will be included in the next performance period 
activities cycle. We will consider the IAUR list we make decisions on 
which improvement activities to include in a future Improvement 
Activities Inventory. We will analyze the IAUR list while considering 
the criteria for inclusion of improvement activities as finalized in 
section II.C.6.e.(7)(b) of this final rule with comment period.
    In addition, in the CY 2018 Quality Payment Program proposed rule 
(82 FR 30056), we proposed that for the formal Annual Call for 
Activities, only activities submitted by March 1 would be considered 
for inclusion in the Improvement Activities Inventory for the 
performance periods occurring in the following calendar year. In other 
words, we will accept improvement activities at any time throughout the 
year, however, we will only consider those improvement activities that 
are received by the March 1 deadline for the following performance 
period. This proposal was slightly different than the Call for Measures 
timeline. The Annual Call for Measures requires a 2-year implementation 
timeline, because the measures being considered for inclusion in MIPS 
undergo the pre-rulemaking process with review by the Measures 
Application Partnership (MAP) (81 FR 77153). In order to decrease the 
timeframe for activity implementation, we did not propose that 
improvement activities also undergo MAP review. Our intention is that 
while we we will accept improvement activities at any time throughout 
the year, we will close the Annual Call for Activities submissions by 
March 1 before the applicable performance period, which would enable us 
to propose the new improvement activities for adoption in the same 
year's rulemaking cycle for implementation in the following year. When 
submissions are received after the March 1 deadline then that 
submission will be included in the next performance period activities 
cycle. For example, an improvement activity submitted to the IAUR prior 
to March 1, 2018 could be considered for performance periods beginning 
in 2019. If an improvement activity submission is submitted April 1, 
2018 then the submission could be considered for performance periods 
beginning in 2020.
    In addition, in the CY 2018 Quality Payment Program proposed rule 
(82 FR 30056), we proposed that we would add new improvement activities 
to the inventory through notice-and-comment rulemaking.
    We invited public comment on our proposals.
    Final Action: We did not receive any public comments on these 
proposals. Therefore, we are finalizing our proposals, as proposed, to: 
(1) Accept submissions for prospective improvement activities at any 
time during the performance period for the Annual Call for Activities 
and create an Improvement Activities under Review (IAUR) list; (2) only 
consider prospective activities submitted by March 1 for inclusion in 
the Improvement Activities Inventory for the performance periods 
occurring in the following calendar year; and (3) add new improvement 
activities to the inventory through notice-and-comment rulemaking.
(8) Removal of Improvement Activities
    In future years, we anticipate developing a process and 
establishing criteria for identifying activities for removal from the 
Improvement Activities Inventory through the Annual Call for Activities 
process. We anticipate proposing these requirements in the future 
through notice-and-comment rulemaking. In the CY 2018 Quality Payment 
Program proposed rule (82 FR 30056), we invited public comments on what 
criteria should be

[[Page 53661]]

used to identify improvement activities for removal from the 
Improvement Activities Inventory.
    We received a few comments on this topic and will take them into 
consideration for future rulemaking.
(9) Approach for Adding New Subcategories
    In the CY 2017 Quality Payment Program final rule (81 FR 77197), we 
finalized the following criteria for adding a new subcategory to the 
improvement activities performance category:
     The new subcategory represents an area that could 
highlight improved beneficiary health outcomes, patient engagement and 
safety based on evidence.
     The new subcategory has a designated number of activities 
that meet the criteria for an improvement activity and cannot be 
classified under the existing subcategories.
     Newly identified subcategories would contribute to 
improvement in patient care practices or improvement in performance on 
quality measures and cost performance categories.
    In the CY 2018 Quality Payment Program proposed rule at (82 FR 
30056), while we did not propose any changes to the approach for adding 
new subcategories for the improvement activities performance category, 
we did propose that in future years of the Quality Payment Program, we 
would add new improvement activities subcategories through notice-and-
comment rulemaking. We did not receive any comments on this proposal 
and are finalizing, as proposed, that in future years of the Quality 
Payment Program, we will add new improvement activities subcategories 
through notice-and-comment rulemaking.
    In the CY 2018 Quality Payment Program proposed rule at (82 FR 
30056), we also sought comments on new improvement activities 
subcategories for future consideration. In particular, in the CY 2017 
Quality Payment Program final rule (81 FR 77194), several stakeholders 
have suggested that a separate subcategory for improvement activities 
specifically related to health IT would make it easier for MIPS 
eligible clinicians and vendors to understand and earn points toward 
their final score through the use of health IT. Such a health IT 
subcategory could include only improvement activities that are 
specifically related to the advancing care information performance 
category measures and allow MIPS eligible clinicians to earn credit in 
the improvement activities performance category, while receiving a 
bonus in the advancing care information performance category as well. 
In the CY 2018 Quality Payment Program proposed rule (82 FR 30056), we 
sought suggestions on how a health IT subcategory within the 
improvement activities performance category could be structured to 
provide MIPS eligible clinicians with flexible opportunities to gain 
experience in using CEHRT and other health IT to improve their 
practice.
    We received many comments on this topic and will take these into 
consideration for future rulemaking.
(10) CMS Study on Burdens Associated With Reporting Quality Measures
(a) Background
    In the CY 2017 Quality Payment Program final rule (81 FR 77195), we 
finalized specifics regarding the CMS Study on Improvement Activities 
and Measurement including the study purpose, study participation credit 
and requirements, and the study procedure. In the CY 2018 Quality 
Payment Program proposed rule (82 FR 30056), we proposed to modify the 
name of the study to the ``CMS Study on Burdens Associated with 
Reporting Quality Measures'' to more accurately reflect the purpose of 
the study. The study assesses clinician burden and data submission 
errors associated with the collection and submission of clinician 
quality measures for MIPS, enrolling groups of different sizes and 
individuals in both rural and non-rural settings and also different 
specialties. We previously finalized that study participants receive 
full credit in the improvement activities performance category if they 
successfully elect, participate, and submit data to CMS for the full 
calendar year (81 FR 77196). In the CY 2017 final rule (81 FR 77195 
through 77197), we requested comments on the study and received 
generally supportive feedback for the study.
    In the CY 2018 Quality Payment Program proposed rule (82 FR 30056 
through 30057), we did not propose any changes to the study purpose. 
However, we proposed changes to the study participation credit and 
requirements for sample size, how the study sample is categorized into 
groups, and the study procedures for the frequency of surveys, focus 
groups, and quality data submission. These proposals are discussed in 
more detail below.
(b) Sample Size
    In addition to performing descriptive statistics to compare the 
trends in errors and burden between study years 2017 and 2018 as 
previously finalized in the (81 FR 77196), we would like to perform a 
more rigorous statistical analysis with the 2018 data, which will 
require a larger sample size. Therefore, in the CY 2018 Quality Payment 
Program proposed rule (82 FR 30056), we proposed increasing the sample 
size for CY 2018 and beyond to provide the minimum sample needed to get 
a significant result with adequate power; that is, we proposed 
increasing the number of the study participants to provide the minimum 
needed to make a meaningful and factual conclusion out of the study. 
This is described in more detail below. The sample size, as finalized 
in the CY 2017 Quality Payment Program final rule (81 FR 77196), for 
performance periods occurring in CY 2017 consisted of 42 MIPS groups as 
stated by MIPS criteria from the following seven categories:
     10 urban individual or groups of <3 eligible clinicians.
     10 rural individual or groups of <3 eligible clinicians.
     10 groups of 3-8 eligible clinicians.
     5 groups of 8-20 eligible clinicians.
     3 groups of 20-100 eligible clinicians.
     2 groups of 100 or greater eligible clinicians.
     2 specialty groups.
    In the CY 2018 Quality Payment Program proposed rule (82 FR 30057), 
we proposed to increase the sample size for the performance periods 
occurring in CY 2018 to a minimum of:
     20 urban individual or groups of <3 eligible clinicians,--
(broken down into 10 individuals and 10 groups).
     20 rural individual or groups of <3 eligible clinicians--
(broken down into 10 individuals and 10 groups).
     10 groups of 3-8 eligible clinicians.
     10 groups of 8-20 eligible clinicians.
     10 groups of 20-100 eligible clinicians.
     10 groups of 100 or greater eligible clinicians.
     6 groups of >20 eligible clinicians reporting as 
individuals--(broken down into 3 urban and 3 rural).
     6 specialty groups--(broken down into 3 reporting 
individually and 3 reporting as a group).
     Up to 10 non-MIPS eligible clinicians reporting as a group 
or individual (any number of individuals and any group size).
(c) Study Procedures
(i) Frequency of Survey and Focus Group
    In the CY 2018 Quality Payment Program proposed rule (82 FR 30057), 
we also proposed changes to the study procedures. In the CY 2017 
Quality

[[Page 53662]]

Payment Program final rule (81 FR 77196), we finalized that for 
transition year of MIPS, study participants were required to attend a 
monthly focus group to share lessons learned in submitting quality data 
along with providing survey feedback to monitor effectiveness. However, 
an individual MIPS eligible clinician or group who chooses to report 
all 6 measures within a period of 90 days may not need to be a part of 
all of the focus groups and survey sessions after their first focus 
group and survey following the measurement data submission (81 FR 
77196). This is because they may have nothing new to contribute in 
terms of discussion of errors or clinician burdens (81 FR 77196). This 
also applied to MIPS eligible clinicians that submitted only three MIPS 
measures within the performance period, if all three measures within 
the 90-day period or at one submission (81 FR 77196). We finalized that 
all study participants would participate in surveys and focus group 
meetings at least once after each measures data submission (81 FR 
77196). For those who elect to report data for a 90-day period, we made 
further engagement optional (81 FR 77196).
    In order to prevent or reduce study participants from incurring any 
more significant additional administrative work as compared to other 
MIPS eligible clinicians not participating in the study, in the CY 2018 
Quality Payment Program proposed rule (82 FR 30057), we proposed that 
for Quality Payment Program Year 2 and future years, that study 
participants would be required to attend as frequently as four monthly 
surveys and focus group sessions throughout the year, but certain study 
participants would be able to attend less frequently. In other words, 
study participants would be required to attend a maximum of four 
surveys and focus group sessions throughout the year.
(ii) Data Submission
    We previously required study measurement data to be collected at 
baseline and then at every 3 months (quarterly basis) afterwards for 
the duration of the calendar year (81 FR 77196). We also finalized a 
minimum requirement of three MIPS quality measures, four times within 
the year (81 FR 77196). We stated that we believe this is inconsistent 
with clinicians reporting a full year's data, as we believe some study 
participants may choose to submit data for all measures at one time, or 
alternatively, may choose to submit data up to six times during the 1-
year period (82 FR 30057).
    As a result, in the CY 2018 Quality Payment Program proposed rule 
(82 FR 30057), we proposed, for the Quality Payment Program Year 2 and 
future years, to offer study participants flexibility in their 
submissions such that they could submit all their quality measures data 
at once, as allowed in the MIPS program, and participate in study 
surveys and focus groups, while still earning improvement activities 
credit.
    We invited public comments on our proposals.
    Comment: A few commenters supported the proposal to examine the 
challenges and costs of reporting quality measures by expanding, and 
aptly renaming the ``CMS Study on Burdens Associated with Reporting 
Quality Measures.''
    Response: We thank the commenters for their support.
    Comment: A few commenters encouraged CMS to automate the process to 
reduce administrative burden and publicly share the survey results.
    Response: We note the suggestion to automate the process (that is, 
the measure data submission process) to reduce administrative burden, 
and will take this into consideration as we craft future policies. We 
also note that the current study survey and focus group have open ended 
questions that ask study participants about their recommendations and 
opinions on the ease and complexities of technology on the process. 
Furthermore, we intend to make the results of the study public 
immediately after the end of the study year CY 2018 (summer 2019) to 
all study participants, relevant stakeholders, and on the CMS Web site.
    Comment: A few commenters suggested that CMS consider additional 
study inclusion factors, such as: Practices and clinicians located in 
both urban and rural HPSAs and clinicians who serve a high proportion 
of low-income patients and patients of color.
    Response: The study selection criteria already includes; but is not 
limited to, rural, urban and geographical location (based on 
demographic characteristics) (81 FR 77195). For study years CY 2017 and 
CY 2018, we are able to analyze and compare clinicians who serve at 
both rural and urban HPSAs, based on participant's zip codes collected 
during recruitment. Additionally, we will consider for future 
rulemaking further efforts to include proportionate HPSAs and minority 
patients in the recruitment and screening of the study participants.
    Final Action: After consideration of the public comments we 
received, we are finalizing our proposals for the CY 2018 and beyond as 
proposed, to: (1) Modify the name of the study to the ``CMS Study on 
Burdens Associated with Reporting Quality Measures;'' (2) increase the 
sample size for CY 2018 and beyond as discussed previously in this 
final rule with comment period; (3) require study participants to 
attend as frequently as four monthly surveys and focus group sessions 
throughout the year; and (4) for the Quality Payment Program Year 2 and 
future years, offer study participants flexibility in their submissions 
such that they can submit all their quality measures data at once and 
participate in study surveys and focus groups while still earning 
improvement activities credit.
    It must be noted that although the aforementioned activities 
constitute an information collection request as defined in the 
implementing regulations of the Paperwork Reduction Act (PRA) of 1995 
(5 CFR 1320), the associated burden is exempt from application of the 
Paperwork Reduction Act. Specifically, section 1848(s)(7) of the Act, 
as added by section 102 of the MACRA (Pub. L. 114-10) states that 
Chapter 35 of title 44, United States Code, shall not apply to the 
collection of information for the development of quality measures. Our 
goals for new measures are to develop new high quality, low cost 
measures that are meaningful, easily understandable and operable, that 
also, reliably and validly measure what they purport. This study shall 
inform us on the root causes of clinicians' performance measure data 
collection and data submission burdens and challenges that hinders 
accurate and timely quality measurement activities. In addition, this 
study will inform us on the characteristic attributes that our new 
measures must possess to be able to accurately capture and measure the 
priorities and gaps MACRA aims for, as described in the Quality 
Measures Development Plan.\2\ This study, therefore, serves as the 
initial stage of developing new measures and also adapting existing 
measures. We believe that understanding clinician's challenges and 
skepticisms, and especially, understanding the factors that undermine 
the optimal functioning and effectiveness of quality measures are 
requisites of developing measures that are not only measuring what it 
purports but also that are user friendly and understandable for 
frontline clinicians--our main stakeholders in measure development. 
This will lead to the creation of practice-derived, tested measures 
that reduces burden and create a culture of continuous improvement in 
measure development.

[[Page 53663]]

f. Advancing Care Information Performance Category
(1) Background
    Section 1848(q)(2)(A) of the Act includes the meaningful use of 
CEHRT as a performance category under the MIPS. We refer to this 
performance category as the advancing care information performance 
category, and it is reported by MIPS eligible clinicians as part of the 
overall MIPS program. As required by sections 1848(q)(2) and (5) of the 
Act, the four performance categories of the MIPS shall be used in 
determining the MIPS final score for each MIPS eligible clinician. In 
general, MIPS eligible clinicians will be evaluated under all four of 
the MIPS performance categories, including the advancing care 
information performance category.
(2) Scoring
    Section 1848(q)(5)(E)(i)(IV) of the Act states that 25 percent of 
the MIPS final score shall be based on performance for the advancing 
care information performance category. We established at Sec.  
414.1380(b)(4) that the score for the advancing care information 
performance category would be comprised of a base score, performance 
score, and potential bonus points for reporting on certain measures and 
activities. For further explanation of our scoring policies for the 
advancing care information performance category, we refer readers to 81 
FR 77216-77227.
(a) Base Score
    For the CY 2018 performance period, we did not propose any changes 
to the base score methodology as established in the CY 2017 Quality 
Payment Program final rule (81 FR 77217-77223).
(b) Performance Score
    In the CY 2017 Quality Payment Program final rule (81 FR 77223 
through 77226), we finalized that MIPS eligible clinicians can earn 10 
percentage points in the performance score for meeting the Immunization 
Registry Reporting Measure. We proposed to modify our policy for 
scoring the Public Health and Clinical Data Registry Reporting 
Objective beginning with the performance period in CY 2018 because we 
have learned that there are areas of the country where immunization 
registries are not available, and we did not intend to disadvantage 
MIPS eligible clinicians practicing in those areas. We proposed if a 
MIPS eligible clinician fulfills the Immunization Registry Reporting 
Measure, the MIPS eligible clinician would earn 10 percentage points in 
the performance score. If a MIPS eligible clinician cannot fulfill the 
Immunization Registry Reporting Measure, we proposed that the MIPS 
eligible clinician could earn 5 percentage points in the performance 
score for each public health agency or clinical data registry to which 
the clinician reports for the following measures, up to a maximum of 10 
percentage points: Syndromic Surveillance Reporting; Electronic Case 
Reporting; Public Health Registry Reporting; and Clinical Data Registry 
Reporting. A MIPS eligible clinician who chooses to report to more than 
one public health agency or clinical data registry may receive credit 
in the performance score for the submission to more than one agency or 
registry; however, the MIPS eligible clinician would not earn more than 
a total of 10 percentage points for such reporting.
    We further proposed similar flexibility for MIPS eligible 
clinicians who choose to report the measures specified for the Public 
Health Reporting Objective of the 2018 Advancing Care Information 
Transition Objective and Measure set. (In section II.C.6.f.(6)(b) of 
the proposed rule, we proposed to allow MIPS eligible clinicians to 
report using the 2018 Advancing Care Information Transition Objectives 
and Measures in 2018.) We proposed if a MIPS eligible clinician 
fulfills the Immunization Registry Reporting Measure, the MIPS eligible 
clinician would earn 10 percentage points in the performance score. If 
a MIPS eligible clinician cannot fulfill the Immunization Registry 
Reporting Measure, we proposed that the MIPS eligible clinician could 
earn 5 percentage points in the performance score for each public 
health agency or specialized registry to which the clinician reports 
for the following measures, up to a maximum of 10 percentage points: 
Syndromic Surveillance Reporting; Specialized Registry Reporting. A 
MIPS eligible clinician who chooses to report to more than one 
specialized registry or public health agency to submit syndromic 
surveillance data may earn 5 percentage points in the performance score 
for reporting to each one, up to a maximum of 10 percentage points.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: Commenters supported the flexibility that we proposed to 
complete the objective and earn points in the performance score. Other 
commenters stated that they appreciate the options for earning a 
performance score. Most commenters appreciated our intent not to 
disadvantage those clinicians without access to immunization 
registries; however, they stated our proposal to award 5 percentage 
points for reporting to each additional public health agency or 
clinical data registry minimized the value of reporting to other types 
of public health information beyond immunization information. 
Commenters suggested that we award 10 percentage points in the 
performance score for reporting to a single agency or registry.
    Response: We appreciate the suggestion and did not intend to 
disadvantage MIPS eligible clinicians who lack access to immunization 
registries or do not administer immunizations. The Public Health and 
Clinical Data Registry Reporting Objective focuses on the importance of 
the ongoing lines of communication that should exist between MIPS 
eligible clinicians and public health agencies and clinical data 
registries, and we want to encourage reporting to them. These 
registries play an important part in monitoring the health status of 
patients and some, for example syndromic surveillance registries, help 
in the early detection of outbreaks, which is critical to public health 
overall. For these reasons, we are finalizing our proposal with 
modification so that a MIPS eligible clinician may earn 10 percentage 
points in the performance score for reporting to any single public 
health agency or clinical data registry, regardless of whether an 
immunization registry is available to the clinician.
    Comment: One commenter requested that we clarify that the exclusion 
for Immunization Registry Reporting is still available to those who do 
not routinely provide vaccinations.
    Response: No exclusion is available for the Immunization Registry 
Reporting Measure for the advancing care information performance 
category. The Immunization Registry Reporting Measure is part of the 
performance score in which clinicians can select which measures they 
wish to report. If they do not provide vaccinations, then they would 
not report on the Immunization Registry Reporting Measure. The final 
policy we are adopting should provide flexibility for clinicians who do 
not administer immunizations by allowing them to earn performance score 
points for public health reporting that is not related to 
immunizations.
    Final Action: After consideration of the public comments and for 
the reasons noted above, we are finalizing our proposal with 
modification. Rather than awarding 5 percentage points in the 
performance score for each public health agency or clinical data 
registry that a MIPS eligible clinician reports to (for a maximum of 10 
percentage

[[Page 53664]]

points), we are finalizing that a MIPS eligible clinician may earn 10 
percentage points in the performance score for reporting to any single 
public health agency or clinical data registry to meet any of the 
measures associated with the Public Health and Clinical Data Registry 
Reporting Objective (or any of the measures associated with the Public 
Health Reporting Objective of the 2018 Advancing Care Information 
Transition Objectives and Measures, for clinicians who choose to report 
on those measures), regardless of whether an immunization registry is 
available to the clinician. A MIPS eligible clinician can earn only 10 
percentage points in the performance score under this policy, no matter 
how many agencies or registries they report to. This policy will apply 
beginning with the 2018 performance period.
(c) Bonus Score
    In the CY 2017 Quality Payment Program final rule (81 FR 77220 
through 77226), for the Public Health and Clinical Data Registry 
Reporting Objective and the Public Health Reporting Objective, we 
finalized that MIPS eligible clinicians who report to one or more 
public health agencies or clinical data registries beyond the 
Immunization Registry Reporting Measure will earn a bonus score of 5 
percentage points in the advancing care information performance 
category. Based on our proposals discussed above to allow MIPS eligible 
clinicians who cannot fulfill the Immunization Registry Reporting 
Measure to earn additional points in the performance score, we proposed 
to modify this policy so that MIPS eligible clinicians cannot earn 
points in both the performance score and bonus score for reporting to 
the same public health agency or clinical data registry. We proposed to 
modify our policy beginning with the performance period in CY 2018. We 
proposed that a MIPS eligible clinician may earn the bonus score of 5 
percentage points for reporting to at least one additional public 
health agency or clinical data registry that is different from the 
agency/agencies or registry/or registries to which the MIPS eligible 
clinician reports to earn a performance score. A MIPS eligible 
clinician would not receive credit under both the performance score and 
bonus score for reporting to the same agency or registry.
    We proposed that for the Advancing Care Information Objectives and 
Measures, a bonus of 5 percentage points would be awarded if the MIPS 
eligible clinician reports ``yes'' for any one of the following 
measures associated with the Public Health and Clinical Data Registry 
Reporting Objective: Syndromic Surveillance Reporting; Electronic Case 
Reporting; Public Health Registry Reporting; or Clinical Data Registry 
Reporting. We proposed that for the 2018 Advancing Care Information 
Transition Objectives and Measures, a bonus of 5 percent would be 
awarded if the MIPS eligible clinician reports ``yes'' for any one of 
the following measures associated with the Public Health Reporting 
Objective: Syndromic Surveillance Reporting or Specialized Registry 
Reporting. We proposed that to earn the bonus score, the MIPS eligible 
clinician must be in active engagement with one or more additional 
public health agencies or clinical data registries that is/are 
different from the agency or registry that they identified to earn a 
performance score.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: Commenters supported the awarding of bonus points for 
reporting to an additional agency or registry. A commenter supported 
providing bonus points for registry reporting rather than mandating 
registry reporting.
    Response: We appreciate the support for our proposal.
    Comment: One commenter requested that we make it explicitly clear 
that MIPS eligible clinicians cannot earn a bonus score for reporting 
to the same agency or registry that they identified for the purposes of 
earning a performance score.
    Response: Under our final policy discussed above, MIPS eligible 
clinicians may report to a single public health or clinical data 
registry and earn 10 percentage points in the performance score. 
Reporting to a different public health or clinical data registry may 
earn the MIPS eligible clinician five percentage points in the bonus 
score. In order to earn the bonus score, the MIPS eligible clinician 
must be in active engagement with a different public health agency or 
clinical data registry than the one to which they reported to earn the 
10 percentage points for the performance score. We expect to engage in 
education and outreach efforts to ensure MIPS eligible clinicians are 
aware of the policies adopted in this final rule with comment period 
including the policy for earning bonus points for the advancing care 
information performance category.
    Comment: One commenter supported closing the loophole so that a 
MIPS eligible clinician cannot receive double credit under both the 
performance score and bonus score for reporting to the same agency or 
registry.
    Response: We appreciate the support for our proposal. As we 
proposed, MIPS eligible clinician cannot receive credit under both the 
performance score and bonus score for reporting to the same public 
health agency or registry.
    Final Action: After consideration of the public comments that we 
received, we are adopting our proposal as proposed and updating the 
regulation text at Sec.  414.1380(b)(4)(C)(1).
(d) Improvement Activities Bonus Score under the Advancing Care 
Information Performance Category
    In the CY 2017 Quality Payment Program final rule (81 FR 77202), we 
discussed our approach to the measurement of the use of health IT to 
allow MIPS eligible clinicians and groups the flexibility to implement 
health IT in a way that supports their clinical needs. Toward that end, 
we adopted a policy to award a bonus score to MIPS eligible clinicians 
who use CEHRT to complete certain activities in the improvement 
activities performance category based on our belief that the use of 
CEHRT in carrying out these activities could further the outcomes of 
clinical practice improvement.
    We adopted a final policy to award a 10 percent bonus for the 
advancing care information performance category if a MIPS eligible 
clinician attests to completing at least one of the improvement 
activities we have specified using CEHRT (81 FR 77209). We referred 
readers to Table 8 in the CY 2017 Quality Payment Program final rule 
(81 FR 77202-77209) for a list of the improvement activities eligible 
for the advancing care information performance category bonus. We 
proposed to expand this policy beginning with the CY 2018 performance 
period by identifying additional improvement activities in Table 6 (82 
FR 30060-30063) that would be eligible for the advancing care 
information performance category bonus score if they are completed 
using CEHRT functionality.
    The following is a summary of the public comments received on this 
proposal and our responses:
    Comment: One commenter supported rewarding clinicians who used 
CEHRT to perform improvement activities. Other commenters appreciated 
the proposed additions to the list of improvement activities using 
CEHRT that would be eligible for the bonus.
    Response: We appreciate the support as we continue to believe that 
offering this bonus will encourage MIPS eligible clinicians to use 
CEHRT not only to

[[Page 53665]]

document patient care, but also to improve their clinical practices by 
using CEHRT in a meaningful manner that supports clinical practice 
improvement. We refer readers to Table 6 which lists all improvement 
activities eligible for the advancing care information performance 
category improvement activity bonus in 2018.
    Comment: One commenter recommended that MIPS eligible clinicians 
and groups that attest to completing one or more of the improvement 
activities using CEHRT should not only earn improvement activity credit 
but also automatically earn the base score for the advancing care 
information performance category, amounting to 50 percent of the 
advancing care information performance category.
    Response: We appreciate the commenter's input and continue to be 
interested in options for incentivizing clinicians to use CEHRT in the 
completion of improvement activities. We will take this comment under 
consideration for future rulemaking on this topic.
    Final Action: After consideration of the public comments, we are 
finalizing with modifications the list of improvement activities shown 
in Table 6 that will be eligible for the advancing care information 
performance category bonus score beginning with the 2018 performance 
period if they are completed using CEHRT. We refer readers to Table F: 
New Improvement Activities for the Quality Payment Program Year 2 and 
Future Years and Table G: Improvement Activities with Changes for the 
Quality Payment Program Year 2 and Future Years for more information on 
modifications to the Improvement Activities that were proposed.

Table 6--Improvement Activities Eligible for the Advancing Care Information Performance Category Bonus Beginning
                                        With the 2018 Performance Period
----------------------------------------------------------------------------------------------------------------
                                                                               Improvement
     Improvement activity                                                       activity       Related advancing
     performance category         Activity name           Activity             performance      care information
          subcategory                                                        category weight      measure(s) *
----------------------------------------------------------------------------------------------------------------
Expanded Practice Access......  Provide 24/7       Provide 24/7 access to  Medium............  Provide Patient
                                 access to          MIPS eligible                               Access.
                                 eligible           clinicians, groups,                        Secure Messaging.
                                 clinicians or      or care teams for                          Send A Summary of
                                 groups who have    advice about urgent                         Care.
                                 real-time access   and emergent care                          Request/Accept
                                 to patient's       (for example, MIPS                          Summary of Care.
                                 medical record.    eligible clinician
                                                    and care team access
                                                    to CEHRT, cross-
                                                    coverage with access
                                                    to CEHRT, or protocol-
                                                    driven nurse line
                                                    with access to CEHRT)
                                                    that could include
                                                    one or more of the
                                                    following:
                                                    Expanded
                                                    hours in evenings and
                                                    weekends with access
                                                    to the patient
                                                    medical record (for
                                                    example, coordinate
                                                    with small practices
                                                    to provide alternate
                                                    hour office visits
                                                    and urgent care);
                                                    Use of
                                                    alternatives to
                                                    increase access to
                                                    care team by MIPS
                                                    eligible clinicians
                                                    and groups, such as e-
                                                    visits, phone visits,
                                                    group visits, home
                                                    visits and alternate
                                                    locations (for
                                                    example, senior
                                                    centers and assisted
                                                    living centers); and/
                                                    or
                                                    Provision of
                                                    same-day or next-day
                                                    access to a
                                                    consistent MIPS
                                                    eligible clinician,
                                                    group or care team
                                                    when needed for
                                                    urgent care or
                                                    transition
                                                    management.
Patient Safety and Practice     Communication of   A MIPS eligible         Medium............  Secure Messaging.
 Assessment.                     Unscheduled        clinician providing                        Send A Summary of
                                 Visit for          unscheduled care                            Care.
                                 Adverse Drug       (such as an emergency                      Request/Accept
                                 Event and Nature   room, urgent care, or                       Summary of Care.
                                 of Event.          other unplanned
                                                    encounter) attests
                                                    that, for greater
                                                    than 75 percent of
                                                    case visits that
                                                    result from a
                                                    clinically
                                                    significant adverse
                                                    drug event, the MIPS
                                                    eligible clinician
                                                    transmits
                                                    information,
                                                    including through the
                                                    use of CEHRT to the
                                                    patient's primary
                                                    care clinician
                                                    regarding both the
                                                    unscheduled visit and
                                                    the nature of the
                                                    adverse drug event
                                                    within 48 hours. A
                                                    clinically
                                                    significant adverse
                                                    event is defined as a
                                                    medication-related
                                                    harm or injury such
                                                    as side-effects,
                                                    supratherapeutic
                                                    effects, allergic
                                                    reactions, laboratory
                                                    abnormalities, or
                                                    medication errors
                                                    requiring urgent/
                                                    emergent evaluation,
                                                    treatment, or
                                                    hospitalization.
Patient Safety and Practice     Consulting AUC     Clinicians attest that  High..............  Clinical Decision
 Assessment.                     using clinical     they are consulting                         Support (CEHRT
                                 decision support   specified applicable                        function only).
                                 when ordering      AUC through a
                                 advanced           qualified clinical
                                 diagnostic         decision support
                                 imaging.           mechanism for all
                                                    applicable imaging
                                                    services furnished in
                                                    an applicable
                                                    setting, paid for
                                                    under an applicable
                                                    payment system, and
                                                    ordered on or after
                                                    January 1, 2018. This
                                                    activity is for
                                                    clinicians that are
                                                    early adopters of the
                                                    Medicare AUC program
                                                    (2018 performance
                                                    year) and for
                                                    clinicians that begin
                                                    the Medicare AUC
                                                    program in future
                                                    years as specified in
                                                    our regulation at
                                                    Sec.   414.94. The
                                                    AUC program is
                                                    required under
                                                    section 218 of the
                                                    Protecting Access to
                                                    Medicare Act of 2014.
                                                    Qualified mechanisms
                                                    will be able to
                                                    provide a report to
                                                    the ordering
                                                    clinician that can be
                                                    used to assess
                                                    patterns of image-
                                                    ordering and improve
                                                    upon those patterns
                                                    to ensure that
                                                    patients are
                                                    receiving the most
                                                    appropriate imaging
                                                    for their individual
                                                    condition.
Patient Safety and Practice     Cost Display for   Implementation of a     Medium............  Clinical Decision
 Assessment.                     Laboratory and     cost display for                            Support (CEHRT
                                 Radiographic       laboratory and                              function only).
                                 Orders.            radiographic orders,
                                                    such as costs that
                                                    can be obtained
                                                    through the Medicare
                                                    clinical laboratory
                                                    fee schedule.

[[Page 53666]]

 
Population Management.........  Glycemic           For at-risk outpatient  Medium............  Patient-Specific
                                 Screening          Medicare                                    Education.
                                 Services.          beneficiaries,                             Patient Generated
                                                    individual MIPS                             Health Data or
                                                    eligible clinicians                         Data from Non-
                                                    and groups must                             clinical
                                                    attest to                                   Settings.
                                                    implementation of
                                                    systematic preventive
                                                    approaches in
                                                    clinical practice for
                                                    at least 60 percent
                                                    for the 2018
                                                    performance period
                                                    and 75 percent in
                                                    future years, of
                                                    CEHRT with
                                                    documentation of
                                                    screening patients
                                                    for abnormal blood
                                                    glucose according to
                                                    current U.S.
                                                    Preventive Services
                                                    Task Force (USPSTF)
                                                    and/or American
                                                    Diabetes Association
                                                    (ADA) guidelines.
Population Management.........  Glycemic           For outpatient          High..............  Patient Generated
                                 management         Medicare                                    Health Data.
                                 services.          beneficiaries with                         Clinical
                                                    diabetes and who are                        Information
                                                    prescribed                                  Reconciliation.
                                                    antidiabetic agents                        Clinical Decision
                                                    (for example,                               Support, CCDS,
                                                    insulin,                                    Family Health
                                                    sulfonylureas), MIPS                        History (CEHRT
                                                    eligible clinicians                         functions only).
                                                    and groups must
                                                    attest to having:
                                                   For the first
                                                    performance period,
                                                    at least 60 percent
                                                    of medical records
                                                    with documentation of
                                                    an individualized
                                                    glycemic treatment
                                                    goal that:
                                                   [cir] Takes into
                                                    account patient-
                                                    specific factors,
                                                    including, at least
                                                    (1) age, (2)
                                                    comorbidities, and
                                                    (3) risk for
                                                    hypoglycemia, and.
                                                   [cir] Is reassessed at
                                                    least annually.
                                                   The performance
                                                    threshold will
                                                    increase to 75
                                                    percent for the
                                                    second performance
                                                    period and onward.
                                                   Clinicians would
                                                    attest that, 60
                                                    percent for first
                                                    year, or 75 percent
                                                    for the second year,
                                                    of their medical
                                                    records that document
                                                    individualized
                                                    glycemic treatment
                                                    represent patients
                                                    who are being treated
                                                    for at least 90 days
                                                    during the
                                                    performance period.
Population Management.........  Glycemic           For at-risk outpatient  Medium............  Patient-Specific
                                 Referring          Medicare                                    Education.
                                 Services.          beneficiaries,                             Patient Generated
                                                    individual MIPS                             Health Data or
                                                    eligible clinicians                         Data from Non-
                                                    and groups must                             clinical
                                                    attest to                                   Settings.
                                                    implementation of
                                                    systematic preventive
                                                    approaches in
                                                    clinical practice for
                                                    at least 60 percent
                                                    for the CY 2018
                                                    performance period
                                                    and 75 percent in
                                                    future years, of
                                                    CEHRT with
                                                    documentation of
                                                    referring eligible
                                                    patients with
                                                    prediabetes to a CDC-
                                                    recognized diabetes
                                                    prevention program
                                                    operating under the
                                                    framework of the
                                                    National Diabetes
                                                    Prevention Program.
Population Management.........  Anticoagulant      Individual MIPS         High..............  Provide Patient
                                 management         eligible clinicians                         Access.
                                 improvements.      and groups who                             Patient-Specific
                                                    prescribe oral                              Education.
                                                    Vitamin K antagonist                       View, Download,
                                                    therapy (warfarin)                          Transmit.
                                                    must attest that, for                      Secure Messaging.
                                                    60 percent of                              Patient Generated
                                                    practice patients in                        Health Data or
                                                    the transition year                         Data from Non-
                                                    and 75 percent of                           Clinical
                                                    practice patients in                        Setting.
                                                    Quality Payment                            Send a Summary of
                                                    Program Year 2 and                          Care.
                                                    future years, their                        Request/Accept
                                                    ambulatory care                             Summary of Care.
                                                    patients receiving                         Clinical
                                                    warfarin are being                          Information
                                                    managed by one or                           Reconciliation
                                                    more of the following                       Exchange.
                                                    improvement                                Clinical Decision
                                                    activities;.                                Support (CEHRT
                                                    Patients are                        Function Only).
                                                    being managed by an
                                                    anticoagulant
                                                    management service,
                                                    that involves
                                                    systematic and
                                                    coordinated care,
                                                    incorporating
                                                    comprehensive patient
                                                    education, systematic
                                                    prothrombin time (PT-
                                                    INR) testing,
                                                    tracking, follow-up,
                                                    and patient
                                                    communication of
                                                    results and dosing
                                                    decisions;.
                                                    Patients are
                                                    being managed
                                                    according to
                                                    validated electronic
                                                    decision support and
                                                    clinical management
                                                    tools that involve
                                                    systematic and
                                                    coordinated care,
                                                    incorporating
                                                    comprehensive patient
                                                    education, systematic
                                                    PT-INR testing,
                                                    tracking, follow-up,
                                                    and patient
                                                    communication of
                                                    results and dosing
                                                    decisions;.
                                                    For rural or
                                                    remote patients,
                                                    patients are managed
                                                    using remote
                                                    monitoring or
                                                    telehealth options
                                                    that involve
                                                    systematic and
                                                    coordinated care,
                                                    incorporating
                                                    comprehensive patient
                                                    education, systematic
                                                    PT-INR testing,
                                                    tracking, follow-up,
                                                    and patient
                                                    communication of
                                                    results and dosing
                                                    decisions; and/or
                                                    For patients
                                                    who demonstrate
                                                    motivation,
                                                    competency, and
                                                    adherence, patients
                                                    are managed using
                                                    either a patient self-
                                                    testing (PST) or
                                                    patient-self-
                                                    management (PSM)
                                                    program.

[[Page 53667]]

 
Population Management.........  Provide Clinical-  Engaging community      Medium............  Provide Patient
                                 Community          health workers to                           Access.
                                 Linkages.          provide a                                  Patient-Specific
                                                    comprehensive link to                       Education.
                                                    community resources                        Patient-Generated
                                                    through family-based                        Health Data.
                                                    services focusing on
                                                    success in health,
                                                    education, and self-
                                                    sufficiency. This
                                                    activity supports
                                                    individual MIPS
                                                    eligible clinicians
                                                    or groups that
                                                    coordinate with
                                                    primary care and
                                                    other clinicians,
                                                    engage and support
                                                    patients, use of
                                                    CEHRT, and employ
                                                    quality measurement
                                                    and improvement
                                                    processes. An example
                                                    of this community
                                                    based program is the
                                                    NCQA Patient-Centered
                                                    Connected Care (PCCC)
                                                    Recognition Program
                                                    or other such
                                                    programs that meet
                                                    these criteria.
Population Management.........  Advance Care       Implementation of       Medium............  Patient-Specific
                                 Planning.          practices/processes                         Education.
                                                    to develop advance                         Patient-Generated
                                                    care planning that                          Health Data.
                                                    includes: Documenting
                                                    the advance care plan
                                                    or living will within
                                                    CEHRT, educating
                                                    clinicians about
                                                    advance care planning
                                                    motivating them to
                                                    address advance care
                                                    planning needs of
                                                    their patients, and
                                                    how these needs can
                                                    translate into
                                                    quality improvement,
                                                    educating clinicians
                                                    on approaches and
                                                    barriers to talking
                                                    to patients about end-
                                                    of-life and
                                                    palliative care needs
                                                    and ways to manage
                                                    its documentation, as
                                                    well as informing
                                                    clinicians of the
                                                    healthcare policy
                                                    side of advance care
                                                    planning.
Population Management.........  Chronic care and   Proactively manage      Medium............  Provide Patient
                                 preventative       chronic and                                 Access.
                                 care management    preventive care for                        Patient-Specific
                                 for empanelled     empanelled patients                         Education.
                                 patients.          that could include                         View, Download,
                                                    one or more of the                          Transmit.
                                                    following:                                 Secure Messaging.
                                                    Provide                            Patient Generated
                                                    patients annually                           Health Data or
                                                    with an opportunity                         Data from Non-
                                                    for development and/                        Clinical
                                                    or adjustment of an                         Setting.
                                                    individualized plan                        Send A Summary of
                                                    of care as                                  Care.
                                                    appropriate to age                         Request/Accept
                                                    and health status,                          Summary of Care.
                                                    including health risk                      Clinical
                                                    appraisal; gender,                          Information
                                                    age and condition-                          Reconciliation.
                                                    specific preventive                        Clinical Decision
                                                    care services; plan                         Support, Family
                                                    of care for chronic                         Health History
                                                    conditions; and                             (CEHRT functions
                                                    advance care                                only).
                                                    planning;.
                                                    Use condition-
                                                    specific pathways for
                                                    care of chronic
                                                    conditions (for
                                                    example,
                                                    hypertension,
                                                    diabetes, depression,
                                                    asthma and heart
                                                    failure) with
                                                    evidence-based
                                                    protocols to guide
                                                    treatment to target;.
                                                    Use pre-visit
                                                    planning to optimize
                                                    preventive care and
                                                    team management of
                                                    patients with chronic
                                                    conditions;.
                                                    Use panel
                                                    support tools
                                                    (registry
                                                    functionality) to
                                                    identify services
                                                    due;.
                                                    Use reminders
                                                    and outreach (for
                                                    example, phone calls,
                                                    emails, postcards,
                                                    patient portals and
                                                    community health
                                                    workers where
                                                    available) to alert
                                                    and educate patients
                                                    about services due;
                                                    and/or
                                                    Routine
                                                    medication
                                                    reconciliation
Population Management.........  Implementation of  Provide longitudinal    Medium............  Provide Patient
                                 methodologies      care management to                          Access.
                                 for improvements   patients at high risk                      Patient-Specific
                                 in longitudinal    for adverse health                          Education.
                                 care management    outcome or harm that                       Patient Generated
                                 for high risk      could include one or                        Health Data or
                                 patients.          more of the                                 Data from Non-
                                                    following:                                  clinical
                                                    Use a                               Settings.
                                                    consistent method to                       Send A Summary of
                                                    assign and adjust                           Care.
                                                    global risk status                         Request/Accept
                                                    for all empaneled                           Summary of Care.
                                                    patients to allow                          Clinical
                                                    risk stratification                         information
                                                    into actionable risk                        reconciliation.
                                                    cohorts. Monitor the                       Clinical Decision
                                                    risk-stratification                         Support, CCDS,
                                                    method and refine as                        Family Health
                                                    necessary to improve                        History, Patient
                                                    accuracy of risk                            List (CEHRT
                                                    status                                      functions only).
                                                    identification;.
                                                    Use a
                                                    personalized plan of
                                                    care for patients at
                                                    high risk for adverse
                                                    health outcome or
                                                    harm, integrating
                                                    patient goals, values
                                                    and priorities; and/
                                                    or.
                                                    Use on-site
                                                    practice-based or
                                                    shared care managers
                                                    to proactively
                                                    monitor and
                                                    coordinate care for
                                                    the highest risk
                                                    cohort of patients..
Population Management.........  Implementation of  Provide episodic care   Medium............  Send A Summary of
                                 episodic care      management, including                       Care.
                                 management         management across                          Request/Accept
                                 practice.          transitions and                             Summary of Care.
                                                    referrals that could                       Clinical
                                                    include one or more                         Information
                                                    of the following:                           Reconciliation.
                                                    Routine and
                                                    timely follow-up to
                                                    hospitalizations, ED
                                                    visits and stays in
                                                    other institutional
                                                    settings, including
                                                    symptom and disease
                                                    management, and
                                                    medication
                                                    reconciliation and
                                                    management; and/or.
                                                    Managing care
                                                    intensively through
                                                    new diagnoses,
                                                    injuries and
                                                    exacerbations of
                                                    illness..

[[Page 53668]]

 
Population Management.........  Implementation of  Manage medications to   Medium............  Clinical
                                 medication         maximize efficiency,                        Information
                                 management         effectiveness and                           Reconciliation.
                                 practice           safety that could                          Clinical Decision
                                 improvements.      include one or more                         Support,
                                                    of the following:                           Computerized
                                                    Reconcile and                       Physician Order
                                                    coordinate                                  Entry Electronic
                                                    medications and                             Prescribing
                                                    provide medication                          (CEHRT functions
                                                    management across                           only).
                                                    transitions of care
                                                    settings and eligible
                                                    clinicians or groups;.
                                                    Integrate a
                                                    pharmacist into the
                                                    care team; and/or.
                                                    Conduct
                                                    periodic, structured
                                                    medication reviews..
Achieving Health Equity.......  Promote use of     Demonstrate             High..............  Public Health
                                 patient-reported   performance of                              Registry
                                 outcome tools.     activities for                              Reporting.
                                                    employing patient-                         Clinical Data
                                                    reported outcome                            Registry
                                                    (PRO) tools and                             Reporting.
                                                    corresponding                              Patient-Generated
                                                    collection of PRO                           Health Data.
                                                    data (e.g., use of
                                                    PQH-2 or PHQ-9 and
                                                    PROMIS instruments)
                                                    such as patient
                                                    reported Wound
                                                    Quality of Life
                                                    (QoL), patient
                                                    reported Wound
                                                    Outcome, and patient
                                                    reported Nutritional
                                                    Screening.
Care Coordination.............  Practice           Develop pathways to     Medium............  Send a Summary of
                                 Improvements       neighborhood/                               Care.
                                 that Engage        community-based                            Request/Accept
                                 Community          resources to support                        Summary of Care.
                                 Resources to       patient health goals                       Patient-Generated
                                 Support Patient    that could include                          Health Data.
                                 Health Goals.      one or more of the
                                                    following:
                                                    Maintain
                                                    formal (referral)
                                                    links to community-
                                                    based chronic disease
                                                    self-management
                                                    support programs,
                                                    exercise programs and
                                                    other wellness
                                                    resources with the
                                                    potential for
                                                    bidirectional flow of
                                                    information and
                                                    provide a guide to
                                                    available community
                                                    resources..
                                                    Including
                                                    through the use of
                                                    tools that facilitate
                                                    electronic
                                                    communication between
                                                    settings;.
                                                    Screen
                                                    patients for health-
                                                    harming legal needs;
                                                    Screen and
                                                    assess patients for
                                                    social needs using
                                                    tools that are CEHRT
                                                    enabled and that
                                                    include to any extent
                                                    standards-based,
                                                    coded question/field
                                                    for the capture of
                                                    data as is feasible
                                                    and available as part
                                                    of such tool; and/or
                                .................   Provide a
                                                    guide to available
                                                    community resources.
Care Coordination.............  Primary Care       The primary care and    Medium............  Send a Summary of
                                 Physician and      behavioral health                           Care.
                                 Behavioral         practices use the                          Request/Accept
                                 Health Bilateral   same CEHRT system for                       Summary of Care.
                                 Electronic         shared patients or
                                 Exchange of        have an established
                                 Information for    bidirectional flow of
                                 Shared Patients.   primary care and
                                                    behavioral health
                                                    records.
Care Coordination.............  PSH Care           Participation in a      Medium............  Send a Summary of
                                 Coordination.      Perioperative                               Care.
                                                    Surgical Home (PSH)                        Request/Accept
                                                    that provides a                             Summary of Care.
                                                    patient-centered,                          Clinical
                                                    physician-led,                              Information
                                                    interdisciplinary,                          Reconciliation.
                                                    and team-based system                      Health
                                                    of coordinated                              Information
                                                    patient care, which                         Exchange.
                                                    coordinates care from
                                                    pre-procedure
                                                    assessment through
                                                    the acute care
                                                    episode, recovery,
                                                    and post-acute care.
                                                    This activity allows
                                                    for reporting of
                                                    strategies and
                                                    processes related to
                                                    care coordination of
                                                    patients receiving
                                                    surgical or
                                                    procedural care
                                                    within a PSH. The
                                                    clinician must
                                                    perform one or more
                                                    of the following care
                                                    coordination
                                                    activities:
                                                    Coordinate
                                                    with care managers/
                                                    navigators in
                                                    preoperative clinic
                                                    to plan and
                                                    implementation
                                                    comprehensive post
                                                    discharge plan of
                                                    care;
                                                    Deploy
                                                    perioperative clinic
                                                    and care processes to
                                                    reduce post-operative
                                                    visits to emergency
                                                    rooms;.
                                                    Implement
                                                    evidence-informed
                                                    practices and
                                                    standardize care
                                                    across the entire
                                                    spectrum of surgical
                                                    patients; or.
                                                    Implement
                                                    processes to ensure
                                                    effective
                                                    communications and
                                                    education of
                                                    patients' post-
                                                    discharge
                                                    instructions.
Care Coordination.............  Implementation of  Performance of regular  Medium............  Send A Summary of
                                 use of             practices that                              Care.
                                 specialist         include providing                          Request/Accept
                                 reports back to    specialist reports                          Summary of Care.
                                 referring          back to the referring                      Clinical
                                 clinician or       MIPS eligible                               Information
                                 group to close     clinician or group to                       Reconciliation.
                                 referral loop.     close the referral
                                                    loop or where the
                                                    referring MIPS
                                                    eligible clinician or
                                                    group initiates
                                                    regular inquiries to
                                                    specialist for
                                                    specialist reports
                                                    which could be
                                                    documented or noted
                                                    in the CEHRT.
Care Coordination.............  Implementation of  Implementation of       Medium............  Secure Messaging.
                                 documentation      practices/processes,                       Send A Summary of
                                 improvements for   including a                                 Care.
                                 developing         discussion on care,                        Request/Accept
                                 regular            to develop regularly                        Summary of Care.
                                 individual care    updated individual                         Clinical
                                 plans.             care plans for at-                          Information
                                                    risk patients that                          Reconciliation.
                                                    are shared with the
                                                    beneficiary or
                                                    caregiver(s).
                                                    Individual care plans
                                                    should include
                                                    consideration of a
                                                    patient's goals and
                                                    priorities, as well
                                                    as desired outcomes
                                                    of care.

[[Page 53669]]

 
Care Coordination.............  Implementation of  Implementation of       Medium............  Provide Patient
                                 practices/         practices/processes                         Access (formerly
                                 processes for      to develop regularly                        Patient Access).
                                 developing         updated individual                         View, Download,
                                 regular            care plans for at-                          Transmit.
                                 individual care    risk patients that                         Secure Messaging.
                                 plans.             are shared with the                        Patient Generated
                                                    beneficiary or                              Health Data or
                                                    caregiver(s).                               Data from Non-
                                                                                                Clinical
                                                                                                Setting.
Care Coordination.............  Practice           Ensure that there is    Medium............  Send A Summary of
                                 improvements for   bilateral exchange of                       Care.
                                 bilateral          necessary patient                          Request/Accept
                                 exchange of        information to guide                        Summary of Care.
                                 patient            patient care, such as                      Clinical
                                 information.       Open Notes, that                            Information
                                                    could include one or                        Reconciliation.
                                                    more of the
                                                    following:
                                                    Participate
                                                    in a Health
                                                    Information Exchange
                                                    if available; and/or.
                                                    Use
                                                    structured referral
                                                    notes.
Beneficiary Engagement........  Engage Patients    Engage patients and     High..............  Patient-Generated
                                 and Families to    families to guide                           Health Data.
                                 Guide              improvement in the                         Provide Patient
                                 Improvement in     system of care by                           Access.
                                 the System of      leveraging digital                         View, Download,
                                 Care.              tools for ongoing                           or Transmit.
                                                    guidance and
                                                    assessments outside
                                                    the encounter,
                                                    including the
                                                    collection and use of
                                                    patient data for
                                                    return-to-work and
                                                    patient quality of
                                                    life improvement.
                                                    Platforms and devices
                                                    that collect patient-
                                                    generated health data
                                                    (PGHD) must do so
                                                    with an active
                                                    feedback loop, either
                                                    providing PGHD in
                                                    real or near-real
                                                    time to the care
                                                    team, or generating
                                                    clinically endorsed
                                                    real or near-real
                                                    time automated
                                                    feedback to the
                                                    patient. Includes
                                                    patient reported
                                                    outcomes (PROs).
                                                    Examples include
                                                    patient engagement
                                                    and outcomes tracking
                                                    platforms, cellular
                                                    or web-enabled bi-
                                                    directional systems,
                                                    and other devices
                                                    that transmit
                                                    clinically valid
                                                    objective and
                                                    subjective data back
                                                    to care teams.
                                                   Because many consumer-
                                                    grade devices capture
                                                    PGHD (for example,
                                                    wellness devices),
                                                    platforms or devices
                                                    eligible for this
                                                    improvement activity
                                                    must be, at a
                                                    minimum, endorsed and
                                                    offered clinically by
                                                    care teams to
                                                    patients to
                                                    automatically send
                                                    ongoing guidance (one
                                                    way). Platforms and
                                                    devices that
                                                    additionally collect
                                                    PGHD must do so with
                                                    an active feedback
                                                    loop, either
                                                    providing PGHD in
                                                    real or near-real
                                                    time to the care
                                                    team, or generating
                                                    clinically endorsed
                                                    real or near-real
                                                    time automated
                                                    feedback to the
                                                    patient (e.g.
                                                    automated patient-
                                                    facing instructions
                                                    based on glucometer
                                                    readings). Therefore,
                                                    unlike passive
                                                    platforms or devices
                                                    that may collect but
                                                    do not transmit PGHD
                                                    in real or near-real
                                                    time to clinical care
                                                    teams, active devices
                                                    and platforms can
                                                    inform the patient or
                                                    the clinical care
                                                    team in a timely
                                                    manner of important
                                                    parameters regarding
                                                    a patient's status,
                                                    adherence,
                                                    comprehension, and
                                                    indicators of
                                                    clinical concern.
Beneficiary Engagement........  Use of CEHRT to    In support of           Medium............  Provide Patient
                                 capture patient    improving patient                           Access.
                                 reported           access, performing                         Patient-Specific
                                 outcomes.          additional activities                       Education.
                                                    that enable capture                        Care Coordination
                                                    of patient reported                         through Patient
                                                    outcomes (for                               Engagement.
                                                    example, home blood
                                                    pressure, blood
                                                    glucose logs, food
                                                    diaries, at-risk
                                                    health factors such
                                                    as tobacco or alcohol
                                                    use, etc.) or patient
                                                    activation measures
                                                    through use of CEHRT,
                                                    containing this data
                                                    in a separate queue
                                                    for clinician
                                                    recognition and
                                                    review.
Beneficiary Engagement........  Engagement of      Access to an enhanced   Medium............  Provide Patient
                                 patients through   patient portal that                         Access.
                                 implementation.    provides up to date                        Patient-Specific
                                                    information related                         Education.
                                                    to relevant chronic
                                                    disease health or
                                                    blood pressure
                                                    control, and includes
                                                    interactive features
                                                    allowing patients to
                                                    enter health
                                                    information and/or
                                                    enables bidirectional
                                                    communication about
                                                    medication changes
                                                    and adherence.
Beneficiary Engagement........  Engagement of      Engage patients,        Medium............  Provide Patient
                                 patients, family   family and caregivers                       Access.
                                 and caregivers     in developing a plan                       Patient-specific
                                 in developing a    of care and                                 Education.
                                 plan of care.      prioritizing their                         View, Download,
                                                    goals for action,                           Transmit
                                                    documented in the                           (Patient
                                                    CEHRT.                                      Action).
                                                                                               Secure Messaging.
Patient Safety and Practice...  Use of decision    Use decision support    Medium............  Clinical Decision
                                 support and        and protocols to                            Support (CEHRT
                                 standardized       manage workflow in                          function only).
                                 treatment          the team to meet
                                 protocols.         patient needs.

[[Page 53670]]

 
Achieving Health Equity.......  Promote Use of     Demonstrate             Medium............  Patient Generated
                                 Patient-Reported   performance of                              Health Data or
                                 Outcome Tools.     activities for                              Data from a Non-
                                                    employing patient-                          Clinical
                                                    reported outcome                            Setting.
                                                    (PRO) tools and                            Public Health and
                                                    corresponding                               Clinical Data
                                                    collection of PRO                           Registry
                                                    data such as the use                        Reporting.
                                                    of PQH-2 or PHQ-9,
                                                    PROMIS instruments,
                                                    patient reported
                                                    Wound Quality of Life
                                                    (QoL), patient
                                                    reported Wound
                                                    Outcome, and patient
                                                    reported Nutritional
                                                    Screening.
Behavioral and Mental Health..  Implementation of  Offer integrated        High..............  Provide Patient
                                 integrated         behavioral health                           Access.
                                 Patient Centered   services to support                        Patient-Specific
                                 Behavioral         patients with                               Education.
                                 Health (PCBH)      behavioral health                          View, Download,
                                 model.             needs, dementia, and                        Transmit.
                                                    poorly controlled                          Secure Messaging.
                                                    chronic conditions.                        Patient Generated
                                                    The services could                          Health Data or
                                                    include one or more                         Data from Non-
                                                    of the following:.                          Clinical
                                                    Use evidence-                       Setting.
                                                    based treatment                            Care coordination
                                                    protocols and                               through Patient
                                                    treatment to goal                           Engagement.
                                                    where appropriate;.                        Send A Summary of
                                                    Use evidence-                       Care.
                                                    based screening and
                                                    case finding
                                                    strategies to
                                                    identify individuals
                                                    at risk and in need
                                                    of services;.
                                                    Ensure
                                                    regular communication
                                                    and coordinated
                                                    workflows between
                                                    eligible clinicians
                                                    in primary care and
                                                    behavioral health;.
                                                    Conduct
                                                    regular case reviews
                                                    for at-risk or
                                                    unstable patients and
                                                    those who are not
                                                    responding to
                                                    treatment;.
                                                    Use of a
                                                    registry or certified
                                                    health information
                                                    technology
                                                    functionality to
                                                    support active care
                                                    management and
                                                    outreach to patients
                                                    in treatment; and/or
                                                    Integrate                          Request/Accept
                                                    behavioral health and                       Summary of Care.
                                                    medical care plans
                                                    and facilitate
                                                    integration through
                                                    co-location of
                                                    services when
                                                    feasible; and/or
                                                    Participate
                                                    in the National
                                                    Partnership to
                                                    Improve Dementia Care
                                                    Initiative, which
                                                    promotes a
                                                    multidimensional
                                                    approach that
                                                    includes public
                                                    reporting, state-
                                                    based coalitions,
                                                    research, training,
                                                    and revised surveyor
                                                    guidance.
Behavioral and Mental Health..  Electronic Health  Enhancements to CEHRT   Medium............  Patient Generated
                                 Record             to capture additional                       Health Data or
                                 Enhancements for   data on behavioral                          Data from Non-
                                 BH data capture.   health (BH)                                 Clinical
                                                    populations and use                         Setting.
                                                    that data for                              Send A Summary of
                                                    additional decision-                        Care.
                                                    making purposes (for                       Request/Accept
                                                    example, capture of                         Summary of Care.
                                                    additional BH data                         Clinical
                                                    results in additional                       Information
                                                    depression screening                        Reconciliation.
                                                    for at-risk patient
                                                    not previously
                                                    identified).
----------------------------------------------------------------------------------------------------------------

(3) Performance Periods for the Advancing Care Information Performance 
Category
    In the CY 2017 Quality Payment Program final rule (81 FR 77210 
through 77211), we established a performance period for the advancing 
care information performance category to align with the overall MIPS 
performance period of one full year to ensure all four performance 
categories are measured and scored based on the same period of time. We 
stated for the first and second performance periods of MIPS (CYs 2017 
and 2018), we will accept a minimum of 90 consecutive days of data and 
encourage MIPS eligible clinicians to report data for the full year 
performance period. We proposed the same policy for the advancing care 
information performance category for the performance period in CY 2019, 
Quality Payment Program Year 3, and would accept a minimum of 90 
consecutive days of data in CY 2019.
    Comment: Commenters supported the continuation of a performance 
period of a minimum of 90 consecutive days of data in CY 2019. Some 
stated that maintaining the 90-day performance period for the first 3 
years of MIPS is important to add stability for the reporting on the 
performance category. One commenter requested that we maintain the 90-
day performance period for the advancing care information performance 
category in perpetuity as a shorter period enables physicians to adopt 
innovative uses of technology and permits flexibility to test new 
health IT solutions.
    Response: While we believe a 90-day performance period is 
appropriate for advancing care information for the 2017, 2018 and 2019 
performance periods, we believe it is premature to establish the 
performance periods for any additional years at this time. We will 
consider creating a 90-day performance period for 2020 and beyond and 
may address this issue in future rulemaking.
    Comment: A few commenters expressed their disappointment that we 
proposed another 90-day performance period for 2019 and urged us to 
move to full calendar year reporting as soon as possible. They stated 
that patients and families should be able to experience the benefits of 
health IT--getting questions answered through secure email, or having 
summary of care records incorporated into new providers' health records 
-any day of the year, rather than a particular three-month period.
    Response: Although we proposed that the MIPS performance period for 
the advancing care information performance category would be a minimum 
of 90 consecutive days, MIPS eligible clinicians have the option to 
submit data for longer periods up to a full calendar year. Furthermore, 
we believe

[[Page 53671]]

that once the functionality in the 2015 Edition CEHRT is implemented, 
MIPS eligible clinicians will use it all the time.
    Final Action: After consideration of the public comments, we are 
adopting our policy as proposed. We will accept a minimum of 90 
consecutive days of data in CY 2019 and are revising Sec.  
414.1320(d)(1).
(4) Certification Requirements
    In the CY 2017 Quality Payment Program final rule (81 FR 77211 
through 77213), we outlined the requirements for MIPS eligible 
clinicians using CEHRT during the CY 2017 performance period for the 
advancing care information performance category as it relates to the 
objectives and measures they select to report, and also outlined 
requirements for the CY 2018 performance period. We additionally 
adopted a definition of CEHRT at Sec.  414.1305 for MIPS eligible 
clinicians that is based on the definition that applies in the EHR 
Incentive Programs under Sec.  495.4.
    For the CY 2017 performance period, we adopted a policy by which 
MIPS eligible clinicians may use EHR technology certified to either the 
2014 or 2015 Edition certification criteria, or a combination of the 
two. For the CY 2018 performance period, we previously stated that MIPS 
eligible clinicians must use EHR technology certified to the 2015 
Edition to meet the objectives and measures specified for the advancing 
care information performance category. We received significant comments 
from the CY 2017 Quality Payment Program final rule and feedback from 
stakeholders through meetings and listening sessions requesting that we 
extend the use of 2014 Edition CEHRT beyond CY 2017 into CY 2018. Many 
commenters expressed concern over the lack of products certified to the 
2015 Edition. Other commenters stated that switching from the 2014 
Edition to the 2015 Edition requires a large amount of time and 
planning and if it is rushed there is a potential risk to patient 
health. Also, our experience with the transition from EHR technology 
certified to the 2011 Edition to EHR technology certified to the 2014 
Edition did make us aware of the many issues associated with the 
adoption of EHR technology certified to a new Edition. These include 
the time that will be necessary to effectively deploy EHR technology 
certified to the 2015 Edition standards and certification criteria and 
to make the necessary patient safety, staff training, and workflow 
investments to be prepared to report for the advancing care information 
performance category for 2018. Thus, we proposed that MIPS eligible 
clinicians may use EHR technology certified to either the 2014 or 2015 
Edition certification criteria, or a combination of the two for the CY 
2018 performance period. We proposed to amend Sec.  414.1305 to reflect 
this change.
    We further noted, that to encourage new participants to adopt 
certified health IT and to incentivize participants to upgrade their 
technology to 2015 Edition products which better support 
interoperability across the care continuum, we proposed to offer a 
bonus of 10 percentage points under the advancing care information 
performance category for MIPS eligible clinicians who report the 
Advancing Care Information Objectives and Measures for the performance 
period in CY 2018 using only 2015 Edition CEHRT. We proposed to amend 
Sec.  414.1380(b)(4)C)(3) to reflect this change. We proposed this one-
time bonus for CY 2018 to support and recognize MIPS eligible 
clinicians and groups that invest in implementing certified EHR 
technology in their practice. We sought comment on the proposed bonus, 
the proposed amount of percentage points for the bonus, and whether the 
bonus should be limited to new participants in MIPS and small 
practices.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: Most commenters supported our proposal to allow the use of 
2014 Edition or 2015 Edition CEHRT or a combination for the 2018 
performance period. One stated that allowing flexibility allows 
clinicians more time to fully evaluate their EHR optimization in a 
meaningful way that ensures EHR systems are in place, tested thoroughly 
and operating as intended. Many stated that an additional transition 
year would be very helpful in allowing physicians to plan for the 
required upgrades, which can be costly and time-consuming. A few 
commenters supported our proposal because they believed it would delay 
the requirement to report on the Advancing Care Information Objectives 
and Measures derived from meaningful use Stage 3 in 2018.
    Response: We thank commenters for their feedback and support of 
CEHRT flexibility in 2018. We hope that allowing MIPS eligible 
clinicians to use 2014 Edition or 2015 Edition CEHRT or a combination 
of the two in 2018 will allow for a smooth transition to 2015 Edition 
CEHRT.
    Comment: One commenter requested that we affirm that 2015 Edition 
CEHRT will be required for the 2019 performance period so that they can 
plan accordingly.
    Response: Under our current policy as reflected in Sec.  414.1305, 
2015 Edition CEHRT will be required in the performance period in 2019. 
We believe that there are many benefits for MIPS eligible clinicians 
and their patients implementing the 2015 Edition of CEHRT. These 
include enabling health information exchange through new and enhanced 
certification criteria standards, as well as through implementation 
specifications for interoperability. The 2015 Edition also incorporates 
changes that are designed to spur innovation and provide more choices 
to health care providers and patients for the exchange of electronic 
health information, including new Application Programming Interface 
(API) certification criteria.
    Comment: Several commenters stated their disappointment with the 
proposed delayed transition to 2015 Edition CEHRT as they believe that 
it includes significant patient-facing technologies and new 
functionalities to support patient engagement and improve 
interoperability.
    Response: While we understand the concern, we believe that it is 
important to provide MIPS eligible clinicians with flexibility and more 
time to adopt and implement 2015 CEHRT We recognize there is burden 
associated with the development and deployment of each new version of 
CEHRT, which may be labor intensive and expensive for clinicians so we 
believe the additional time will be welcomed. In addition if MIPS 
eligible clinicians are ready to report using the 2015 Edition, we 
encourage them to do so.
    Comment: Most commenters supported our proposal to award a 10 
percentage point bonus for using 2015 Edition CEHRT exclusively in 
2018.
    Response: We appreciate the support for this proposal and believe 
the bonus will incentivize MIPS eligible clinicians to work to 
implement 2015 Edition CEHRT by 2018.
    Comment: Some commenters suggested that we offer a bonus to those 
MIPS eligible clinicians who use a combination of 2014 Edition and 2015 
Edition CEHRT in 2018. Others suggested that the bonus be available not 
only in 2018 but also in 2019. Other commenters requested that the 
bonus be available to all MIPS eligible clinicians regardless of 
whether they are new to the MIPS program or not. Other commenters 
believed that CMS has struck an appropriate balance of minimizing the 
regulatory burden on clinicians not yet prepared to transition to 2015 
Edition CEHRT, while

[[Page 53672]]

incentivizing those clinicians who have transitioned to 2015 Edition 
CEHRT.
    Response: We believe it is appropriate to award the bonus only to 
those MIPS eligible clinicians who are able to use only the 2015 
Edition of CEHRT in 2018. We understand that it is challenging to 
transition from the 2014 Edition to the 2015 Edition of CEHRT and wish 
to incentivize clinicians to complete the transition. We believe this 
bonus will help to incentivize participants to continue the process of 
upgrading from 2014 Edition to 2015 Edition, especially small practices 
where the investment in updated workflows and implementation may 
present unique challenges. We agree with commenters that the bonus 
should be available to all MIPS eligible clinicians who use 2015 
Edition CEHRT exclusively in 2018. In addition, we intend this bonus to 
support and recognize the efforts to report on the Advancing Care 
Information Measures using EHR technology certified to the 2015 
Edition, which include more robust measures using updated standards and 
functions which support interoperability.
    Comment: Several commenters requested that the bonus points 
available for using 2015 Edition CEHRT be raised from 10 percentage 
points to 20 percentage points because it would provide stronger 
incentive for clinicians to upgrade to and implement 2015 Edition CEHRT 
for use in 2018, thereby expanding the availability of 2015 Edition 
enhancements, such as the new open APIs. A few commenters recommended 
that we provide a bonus of 15 percentage points. Commenters expressed 
concern that adding only 10 percentage points to the score for the use 
of 2015 Edition CEHRT is too trivial an incentive and would do little 
to offset the work participants must do to prepare to participate in 
the Quality Payment Program.
    Response: We disagree and believe that a 10 percentage point bonus 
provides an adequate incentive for MIPS eligible clinicians to use 2015 
Edition CEHRT exclusively for a minimum of a 90-day performance period 
in 2018. Additionally, the addition of this 10 percentage point bonus 
would bring the total bonus points available under the advancing care 
information performance category to 25 percentage points. We remind 
readers that a MIPS eligible clinician may earn a maximum score of 165 
percentage points (including the 2015 Edition CEHRT bonus) for the 
advancing care information performance category, but all scores of 100 
percentage points and higher will receive full credit for the category 
(25 percentage points) in the final score.
    Comment: One commenter did not support bonus points for clinicians 
that adopt 2015 Edition CEHRT in 2018 because they do not agree that 
2015 Edition CEHRT enhances a physician's ability to provide higher 
quality care. Another commenter indicated that providing bonus points 
may disadvantage clinicians who have prior experience with CEHRT but 
are unable to fully implement the 2015 Edition due to vendor issues 
beyond their control.
    Response: While we appreciate these concerns, we believe that the 
availability of the bonus is appropriate and we wish to incentivize 
clinicians to complete the transition to 2015 Edition CEHRT in 2018.
    Final Action: After consideration of the public comments, we are 
adopting as proposed our proposal to allow the use of 2014 Edition or 
2015 Edition CEHRT, or a combination of the two Editions, for the 
performance period in 2018. We will offer a one-time bonus of 10 
percentage points under the advancing care information performance 
category for MIPS eligible clinicians who report the Advancing Care 
Information Objectives and Measures for the performance period in CY 
2018 using only 2015 Edition CEHRT. We will not limit the bonus to new 
participants. We are revising Sec. Sec.  414.1305 and 414.1380(b)(4) of 
the regulation text to reflect this policy.
(5) Scoring Methodology Considerations
    Section 1848(q)(5)(E)(i)(IV) of the Act states that 25 percent of 
the MIPS final score shall be based on performance for the advancing 
care information performance category. Further, section 
1848(q)(5)(E)(ii) of the Act, provides that in any year in which the 
Secretary estimates that the proportion of eligible professionals (as 
defined in section 1848(o)(5) of the Act) who are meaningful EHR users 
(as determined under section 1848(o)(2) of the Act) is 75 percent or 
greater, the Secretary may reduce the applicable percentage weight of 
the advancing care information performance category in the MIPS final 
score, but not below 15 percent, and increase the weightings of the 
other performance categories such that the total percentage points of 
the increase equals the total percentage points of the reduction. We 
noted that section 1848(o)(5) of the Act defines an eligible 
professional as a physician, as defined in section 1861(r) of the Act.
    In CY 2017 Quality Payment Program final rule (81 FR 77226-77227), 
we established a final policy, for purposes of applying section 
1848(q)(5)(E)(ii) of the Act, to estimate the proportion of physicians 
as defined in section 1861(r) of the Act who are meaningful EHR users, 
as those physician MIPS eligible clinicians who earn an advancing care 
information performance category score of at least 75 percent for a 
performance period. We established that we will base this estimation on 
data from the relevant performance period, if we have sufficient data 
available from that period. We stated that we will not include in the 
estimation physicians for whom the advancing care information 
performance category is weighted at zero percent under section 
1848(q)(5)(F) of the Act, which we relied on in the CY 2017 Quality 
Payment Program final rule (81 FR 77226 through 77227) to establish 
policies under which we would weigh the advancing care information 
performance category at zero percent of the final score. In addition, 
we proposed not to include in the estimation physicians for whom the 
advancing care information performance category would be weighted at 
zero percent under the proposal in section II.C.6.f.(7) of the proposed 
rule to implement certain provisions of the 21st Century Cures Act 
(that is, physicians who are determined hospital-based or ambulatory 
surgical center-based, or who are granted an exception based on 
significant hardship or decertified EHR technology).
    We stated that we were considering modifications to the policy we 
established in last year's rulemaking to base our estimation of 
physicians who are meaningful EHR users for a MIPS payment year (for 
example, 2019) on data from the relevant performance period (for 
example, 2017). We stated our concern that if in future rulemaking we 
decide to propose to change the weight of the advancing care 
information performance category based on our estimation, such a change 
may cause confusion to MIPS eligible clinicians who are adjusting to 
the MIPS program and believe this performance category will make up 25 
percent of the final score for the 2019 MIPS payment year. We noted the 
earliest we would be able to make our estimation based on 2017 data and 
propose in future rulemaking to change the weight of the advancing care 
information performance category for the 2019 MIPS payment year would 
be in mid-2018, as the deadline for data submission is March 31, 2018. 
We requested public comments on whether this timeframe is sufficient, 
or whether a more extended timeframe would be preferable. We proposed 
to modify our existing policy such that we would base our estimation

[[Page 53673]]

of physicians who are meaningful EHR users for a MIPS payment year on 
data from the performance period that occurs 4 years before the MIPS 
payment year.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: Some commenters supported our proposal because they 
believed it was appropriate to allow additional time to ensure that 
clinicians are aware of the percentage weighting of each MIPS 
performance category. A few commenters stated that more certainty and 
advance notice will offer MIPS eligible clinicians more time to prepare 
and focus resources on areas of most significance.
    Response: We thank commenters for their support and agree that 
additional time to determine whether the advancing care information 
category weight should be reduced is necessary. Once we make a 
determination we will communicate such a change to the percentage 
weighting of each of the MIPS performance categories to MIPS eligible 
clinicians.
    Comment: Some commenters stated that the timeline that we proposed 
was not sufficient. Commenters stated that a proposal to change the 
weight would not be finalized until late in 2018 and would be applied 
to the 2019 MIPS performance period/2021 payment year which does not 
give clinicians sufficient time to be educated and respond to the 
changes in the category weights. Other commenters stated that any 
change to the MIPS program, specifically the possibility of a change in 
the weight of the advancing care information performance category, will 
have a domino effect on various aspects of the program, as well as 
within the health IT space. Based on updated category weight 
allocation, which would change the overall computation of a MIPS score, 
health IT developers will need to make adjustments to their products 
and software accordingly. In turn, those products must be implemented 
by clinicians. For product lifecycles, there needs to be at least 12 
months' notice given for all parties to adequately plan and execute 
these changes. The proposed timeline that CMS has outlined (for 
performance period 2017/payment year 2019, the earliest feedback would 
be in mid-2018 that would in turn effect the weight of performance 
period 2019/payment year 2021) would allow for notification of less 
than a year, and is therefore not sufficient.
    Response: While we understand these concerns, we previously 
finalized our policy to base our estimation of physicians who are 
meaningful EHR users for a MIPS payment year on data from the relevant 
performance period for the MIPS payment year. For example, for the 2019 
MIPS payment year, the performance period is two years prior to the 
payment year, in 2017. We proposed to extend the look-back period to 
the performance period that occurs 4 years before the MIPS payment 
year, which would give additional time for MIPS eligible clinicians and 
health IT developers to adjust to the new weighting prior to the start 
of the actual performance period for the MIPS payment year. We continue 
to believe that this timeframe is sufficient.
    Comment: Some commenters expressed concern with the proposal to 
base CMS' estimation of meaningful EHR users on data from the 
performance period that occurs 4 years before the MIPS payment year. 
According to the commenters, the 4-year look-back period is 
unreasonably long given the rapid pace of technology, especially given 
continued delays in adopting 2015 Edition technology. Commenters 
encouraged CMS to shorten this look-back period. Prematurely reducing 
the advancing care information performance category's weight could 
impair progress towards robust, person-centered uses of health IT.
    Response: While we appreciate these concerns, we also believe that 
it is important to give MIPS eligible clinicians sufficient notice 
before we change the weighting of a category so that they can plan 
appropriately. We note that the earliest data we can use to calculate 
the proportion of physicians who are meaningful EHR users will be the 
data from the 2017 performance period, which will not be available 
until 2018. Under our current policy, 2018 is the earliest we would be 
able to propose in rulemaking to reduce and redistribute the weight of 
the advancing care information performance category for the 2019 MIPS 
payment year, based on the proportion of physicians who were meaningful 
EHR users during the performance period in 2017. As previously stated, 
we believe it is important for MIPS eligible clinicians to be aware of 
this reweighting prior to the relevant performance period during which 
they would be measured for the MIPS payment year, which is why we 
believe the proposed 4-year timeline is more appropriate.
    Comment: Some commenters recommended keeping the advancing care 
information performance category as 25 percent of the MIPS final score 
in years in which 75 percent or more of physicians are meaningful EHR 
users. Other commenters recommended that if the weight of the advancing 
care information performance category is reduced, it should not all be 
redistributed to the quality category. Many commenters suggested that 
it be redistributed to quality and improvement activities performance 
categories particularly for physicians for whom there are not the 
required number of meaningful quality measures.
    Response: We appreciate this input. We intend to make our decision 
about whether to change the performance category weight based on data 
from the performance period that is 4 years prior to the MIPS payment 
year. We have not yet proposed a new weight for the advancing care 
information performance category or to which category or categories the 
points would be distributed.
    Comment: A few commenters stated that it is too early to consider 
reweighting a category before any data has been received or analyzed. 
When reweighting is implemented, they urged CMS to ensure that 
clinicians are informed of the reweighting prior to the performance 
period. Changing the weight of a performance category retrospectively 
would add confusion to an already complex program.
    Response: We have not yet proposed to reduce the weight of the 
performance category. We are simply establishing the timeframe for when 
we would decide whether to reduce and redistribute the weight.
    Comment: Several commenters suggested that any proposed changes to 
the weight of the advancing care information performance category 
resulting from an assessment of the proportion of clinicians who are 
meaningful EHR users, for example, those who achieve an advancing care 
information performance category score of at least 75 percent, should 
be based on at least two to three MIPS performance periods worth of 
data to ensure an accurate baseline.
    Response: We agree that this decision should be made with 
consideration for the reliability and validity of data, however, we 
disagree that it would require multiple performance periods to obtain 
the necessary data to make this determination. We also note that we are 
not proposing to base this decision on any particular year at this 
point in time, we are only addressing the timeframe relationship 
between when the data is reported and when the reweighting would take 
place. For example, should the data show that 75 percent or more 
physicians are considered meaningful users based on data submitted for 
the 2017 performance period, we would propose to reweight the advancing 
care information performance category weight in 2021 instead of 2019. 
We

[[Page 53674]]

believe this policy would allow adequate time for MIPS eligible 
clincians, EHR vendors and other stakeholders to adjust to the new 
scoring structure prior to submitting data for the effected payment 
year.
    Final Action: Based on the public comments and for the reasons 
discussed in the proposed rule, we are adopting our proposal as 
proposed. Our ability to implement this policy will be dependent on the 
availability of data from the performance period that occurs 4 years 
before the MIPS payment year.
(6) Objectives and Measures
(a) Advancing Care Information Objectives and Measures Specifications
    We proposed to maintain for the CY 2018 performance period the 
Advancing Care Information Objectives and Measures as finalized in the 
CY 2017 Quality Payment Program final rule (81 FR 77227 through 77229). 
We proposed the following modifications to certain objectives and 
measures.
    Provide Patient Access Measure: For at least one unique patient 
seen by the MIPS eligible clinician: (1) The patient (or the patient-
authorized representative) is provided timely access to view online, 
download, and transmit his or her health information; and (2) The MIPS 
eligible clinician ensures the patient's health information is 
available for the patient (or patient-authorized representative) to 
access using any application of their choice that is configured to meet 
the technical specifications of the Application Programing Interface 
(API) in the MIPS eligible clinician's CEHRT.
    Proposed definition of timely: Beginning with the 2018 performance 
period, we proposed to define ``timely'' as within 4 business days of 
the information being available to the MIPS eligible clinician. This 
definition of timely is the same as we adopted under the EHR Incentive 
Programs (80 FR 62815).
    Proposed change to the View, Download, Transmit (VDT) Measure: 
During the performance period, at least one unique patient (or patient-
authorized representatives) seen by the MIPS eligible clinician 
actively engages with the EHR made accessible by the MIPS eligible 
clinician by either (1) viewing, downloading or transmitting to a third 
party their health information; or (2) accessing their health 
information through the use of an API that can be used by applications 
chosen by the patient and configured to the API in the MIPS eligible 
clinician's CEHRT; or (3) a combination of (1) and (2). We proposed 
this change because we erroneously described the actions in the measure 
(viewing, downloading or transmitting; or accessing through an API) as 
being taken by the MIPS eligible clinician rather than the patient or 
the patient-authorized representatives. We proposed this change would 
apply beginning with the performance period in 2017.
    Objective: Health Information Exchange.
    Objective: The MIPS eligible clinician provides a summary of care 
record when transitioning or referring their patient to another setting 
of care, receives or retrieves a summary of care record upon the 
receipt of a transition or referral or upon the first patient encounter 
with a new patient, and incorporates summary of care information from 
other health care clinician into their EHR using the functions of 
CEHRT.
    Proposed change to the Objective: The MIPS eligible clinician 
provides a summary of care record when transitioning or referring their 
patient to another setting of care, receives or retrieves a summary of 
care record upon the receipt of a transition or referral or upon the 
first patient encounter with a new patient, and incorporates summary of 
care information from other health care providers into their EHR using 
the functions of CEHRT.
    We inadvertently used the term ``health care clinician'' and 
proposed to replace it with the more appropriate term ``health care 
provider''. We proposed this change would apply beginning with the 
performance period in 2017.
    Send a Summary of Care Measure: For at least one transition of care 
or referral, the MIPS eligible clinician that transitions or refers 
their patient to another setting of care or health care clinician (1) 
creates a summary of care record using CEHRT; and (2) electronically 
exchanges the summary of care record.
    Proposed Change to the Send a Summary of Care Measure: For at least 
one transition of care or referral, the MIPS eligible clinician that 
transitions or refers their patient to another setting of care or 
health care provider (1) creates a summary of care record using CEHRT; 
and (2) electronically exchanges the summary of care record.
    We inadvertently used the term ``health care clinician'' and 
proposed to replace it with the more appropriate term ``health care 
provider''. We proposed this change would apply beginning with the 2017 
performance period.
    Syndromic Surveillance Reporting Measure: The MIPS eligible 
clinician is in active engagement with a public health agency to submit 
syndromic surveillance data from a non-urgent care ambulatory setting 
where the jurisdiction accepts syndromic data from such settings and 
the standards are clearly defined.
    Proposed change to the Syndromic Surveillance Reporting Measure: 
The MIPS eligible clinician is in active engagement with a public 
health agency to submit syndromic surveillance data.
    We proposed this change because we inadvertently finalized the 
measure description that we had proposed for Stage 3 of the EHR 
Incentive Program (80 FR 62866) and not the measure description that we 
finalized (80 FR 62970). We are modifying the proposed change so that 
it does align with the measure description finalized for Stage 3 by 
adding the phrase ``from an urgent care setting'' to the end of the 
measure description.
    In the proposed rule, we noted that we have split the Specialized 
Registry Reporting Measure that we adopted under the 2017 Advancing 
Care Information Transition Objectives and Measures into two separate 
measures, Public Health Registry Reporting and Clinical Data Registry 
Reporting, to better define the registries available for reporting. We 
proposed to allow MIPS eligible clinicians and groups to continue to 
count active engagement in electronic public health reporting with 
specialized registries. We proposed to allow these registries to be 
counted for purposes of reporting the Public Health Registry Reporting 
Measure or the Clinical Data Registry Reporting Measure beginning with 
the 2018 performance period. A MIPS eligible clinician may count a 
specialized registry if the MIPS eligible clinician achieved the phase 
of active engagement as described under ``active engagement option 3: 
production'' in the 2015 EHR Incentive Programs final rule with comment 
period (80 FR 62862 through 62865), meaning the clinician has completed 
testing and validation of the electronic submission and is 
electronically submitting production data to the public health agency 
or clinical data registry.
(b) 2017 and 2018 Advancing Care Information Transition Objectives and 
Measures Specifications
    In the CY 2017 Quality Payment Program final rule (81 FR 77229 
through 77237), we finalized the 2017 Advancing Care Information 
Transition Objectives and Measures for MIPS eligible clinicians using 
EHR technology certified to the 2014 Edition. Because we proposed in 
section II.C.6.f.(4) of the

[[Page 53675]]

proposed rule to continue to allow the use of EHR technology certified 
to the 2014 Edition in the 2018 performance period, we also proposed to 
allow MIPS eligible clinicians to report the 2017 Advancing Care 
Information Transition Objectives and Measures in 2018. We proposed to 
make several modifications identified and described below to the 2017 
Advancing Care Information Transition Objectives and Measures for the 
advancing care information performance category of MIPS for the 2017 
and 2018 performance periods.
    Objective: Patient Electronic Access.
    Objective: The MIPS eligible clinician provides patients (or 
patient-authorized representative) with timely electronic access to 
their health information and patient-specific education.
    Proposed Change to the Objective.
    We proposed to modify this objective beginning with the 2017 
performance period by removing the word ``electronic'' from the 
description of timely access as it was erroneously included in the 
final rule (81 FR 77228).
    Objective: Patient-Specific Education.
    Objective: The MIPS eligible clinician provides patients (or 
patient authorized representative) with timely electronic access to 
their health information and patient-specific education.
    Proposed Change to the Objective: The MIPS eligible clinician uses 
clinically relevant information from CEHRT to identify patient-specific 
educational resources and provide those resources to the patient. We 
inadvertently finalized the description of the Patient Electronic 
Access Objective for the Patient-Specific Education Objective, so that 
the Patient-Specific Education Objective had the wrong description. We 
proposed to correct this error by adopting the description of the 
Patient-Specific Education Objective adopted under modified Stage 2 in 
the 2015 EHR Incentive Programs final rule (80 FR 62809 and 80 FR 
62815). We proposed this change would apply beginning with the 
performance period in 2017.
    Objective: Health Information Exchange.
    Objective: The MIPS eligible clinician provides a summary of care 
record when transitioning or referring their patient to another setting 
of care, receives or retrieves a summary of care record upon the 
receipt of a transition or referral or upon the first patient encounter 
with a new patient, and incorporates summary of care information from 
other health care clinicians into their EHR using the functions of 
CEHRT.
    Proposed change to the Objective: The MIPS eligible clinician 
provides a summary of care record when transitioning or referring their 
patient to another setting of care, receives or retrieves a summary of 
care record upon the receipt of a transition or referral or upon the 
first patient encounter with a new patient, and incorporates summary of 
care information from other health care providers into their EHR using 
the functions of CEHRT.
    We inadvertently used the term ``health care clinician'' and 
proposed to replace it with the more appropriate term ``health care 
provider''. We proposed this change would apply beginning with the 
performance period in 2017.
    Health Information Exchange Measure: The MIPS eligible clinician 
that transitions or refers their patient to another setting of care or 
health care clinician (1) uses CEHRT to create a summary of care 
record; and (2) electronically transmits such summary to a receiving 
health care clinician for at least one transition of care or referral.
    Proposed change to the measure: The MIPS eligible clinician that 
transitions or refers their patient to another setting of care or 
health care provider (1) uses CEHRT to create a summary of care record; 
and (2) electronically transmits such summary to a receiving health 
care provider for at least one transition of care or referral.
    We inadvertently used the term ``health care clinician'' and 
proposed to replace it with the more appropriate term ``health care 
provider''. We proposed this change would apply beginning with the 
performance period in 2017.
    Denominator: Number of transitions of care and referrals during the 
performance period for which the EP was the transferring or referring 
health care clinician.
    Proposed change to the denominator: Number of transitions of care 
and referrals during the performance period for which the MIPS eligible 
clinician was the transferring or referring health care provider. This 
change reflects the change proposed to the Health Information Exchange 
Measure replacing ``health care clinician'' with ``health care 
provider.'' We also inadvertently referred to the EP in the description 
and are replacing ``EP'' with ``MIPS eligible clinician.'' We proposed 
this change would apply beginning with the performance period in 2017.
    Objective: Medication Reconciliation.
    Proposed Objective: We proposed to add a description of the 
Medication Reconciliation Objective beginning with the CY 2017 
performance period, which we inadvertently omitted from the CY 2017 
Quality Payment Program proposed and final rules, as follows:
    Proposed Objective: The MIPS eligible clinician who receives a 
patient from another setting of care or provider of care or believes an 
encounter is relevant performs medication reconciliation. This 
description aligns with the objective adopted for Modified Stage 2 at 
80 FR 62811.
    Medication Reconciliation Measure: The MIPS eligible clinician 
performs medication reconciliation for at least one transition of care 
in which the patient is transitioned into the care of the MIPS eligible 
clinician.
     Numerator: The number of transitions of care or referrals 
in the denominator where the following three clinical information 
reconciliations were performed: Medication list, Medication allergy 
list, and current problem list.
    Proposed Modification to the Numerator.
    Proposed Numerator: The number of transitions of care or referrals 
in the denominator where medication reconciliation was performed.
    We proposed to modify the numerator by removing medication list, 
medication allergy list, and current problem list. These three criteria 
were adopted for Stage 3 (80 FR 62862) but not for Modified Stage 2 (80 
FR 62811). We proposed this change would apply beginning with the 
performance period in 2017.
    The following is a summary of the public comments received on the 
``Advancing Care Information Objectives and Measures'' and the ``2017 
and 2018 Advancing Care Information Transition Objectives and 
Measures'' proposals and our responses:
    Comment: Several commenters were confused by our proposal related 
to specialized registries and active engagement option 3, production, 
believing that the only way to receive credit for the Public Health 
Agency and Clinical Data Registry Reporting Objective is through the 
production option.
    Response: MIPS eligible clinicians may fulfill the Public Health 
Agency and Clinical Data Registry Reporting Objective or the Public 
Health Reporting Objective through any of the active engagement options 
as described at 80 FR 62818-62819: completed registration to submit 
data; testing and validation; or production. Our proposal pertained to 
MIPS eligible clinicians who choose to use option 3, production, for 
specialized registries.
    Comment: Several commenters supported the proposed definition of 
timely for the Patient Electronic Access

[[Page 53676]]

Measure. One stated that the proposed definition supports practice 
workflows where patient information may become available prior to a 
weekend or holiday. This proposal would allow the necessary time for an 
eligible clinician to review and ensure accurate information is made 
available to patients.
    Response: We appreciate the support for our proposal. We sought to 
give MIPS eligible clinicians sufficient time to make information 
available. We specified 4 business days so as not to include holidays 
and weekends.
    Comment: In the interest of reducing administrative burden, a 
commenter encouraged the alignment of the definition of ``timely'' for 
the ``Provide Patient Access Measure'' in the Medicaid EHR Incentive 
Program and the Quality Payment Program. For both programs, they 
supported defining ``timely'' as follows: Providing access to health 
information within 4 business days of the information being available 
to the MIPS eligible clinician, as opposed to the 48 hour standard in 
Stage 3 of the Medicaid EHR Incentive Program.
    Response: We understand that there are two different definitions of 
timely. We proposed 4 business days for MIPS because we believe it 
provides an adequate timeframe for a new program and the clinicians who 
may not have previously participated in the Medicare and Medicaid EHR 
Incentive Programs. We may consider aligning the Medicaid EHR Incentive 
Program definition in the future.
    Comment: One commenter disagreed with our proposal related to the 
Patient Electronic Access Objective and suggested that the definition 
of timely access under the Health Insurance Portability and 
Accountability Act (HIPAA) is appropriate. The commenter stated that 
under the HIPAA Privacy Rule, a covered entity must act on an 
individual's request for access no later than 30 calendar days after 
receipt of the request.
    Response: We disagree and believe that 4 business days will provide 
MIPS eligible clinicians with an adequate amount of time to provide 
their patients with electronic access to their health information. We 
further note that the HIPAA timeframe relates to an individual's 
request for their information and the Patient Electronic Access Measure 
relates to information being made available regardless of whether a 
request is made.
    Comment: One commenter cautioned CMS of the unintended consequences 
related to the proposed definition of providing ``timely'' access for 
patients or their authorized representatives. The commenter stated that 
the proposed definition of timely (4 business days) may result in the 
inability of clinicians to achieve the base score, and thus, any 
advancing care information performance category score.
    Response: While we appreciate this concern, we believe that by 
establishing the definition of timely as 4 business days MIPS eligible 
clinicians should have a sufficient amount of time to fulfill the 
Patient Electronic Access Measure. We also note that you only need to 
provide timely access for one patient to achieve the base score for the 
advancing care information performance category.
    Comment: Most commenters supported the proposed modifications to 
the Advancing Care Information Objectives and Measures as reasonable 
and appropriate. Another commenter stated that until an overhaul of the 
advancing care information performance category is undertaken, they 
support the modifications as proposed and urged CMS to finalize them as 
described.
    Response: We thank commenters for their support of the proposed 
modifications and agree that these modifications should be finalized.
    Comment: Some commenters suggested that we clarify that MIPS 
eligible clinicians may report either the Advancing Care Information 
Objectives and Measures or the Advancing Care Information Transition 
Objectives and Measures using 2015 Edition or 2014 Edition CEHRT.
    Response: For the 2018 performance period, MIPS eligible clinicians 
will have the option to report the Advancing Care Information 
Transition Objectives and Measures using 2014 Edition CEHRT, 2015 
Edition CEHRT, or a combination of 2014 and 2015 Edition CEHRT, as long 
as the EHR technology they possess can support the objectives and 
measures to which they plan to attest. Similarly, MIPS eligible 
clinicians will have the option to attest to the Advancing Care 
Information Objectives and Measures using 2015 Edition CEHRT or a 
combination of 2014 and 2015 Edition CEHRT, as long as their EHR 
technology can support the objectives and measures to which they plan 
to attest.
    Final Action: After considering the public comments that we 
received, we are finalizing our proposals as proposed with one 
modification to the description of the Syndromic Surveillance Reporting 
Measure: The MIPS eligible clinician is in active engagement with a 
public health agency to submit syndromic surveillance data from an 
urgent care setting.

 Table 7--2018 Performance Period Advancing Care Information Performance Category Scoring Methodology Advancing
                                    Care Information Objectives and Measures
----------------------------------------------------------------------------------------------------------------
                                    2018 advancing       Required/not
 2018 advancing care information   care information    required for base   Performance score       Reporting
            objective                   measure           score (50%)         (up to 90%)         requirement
----------------------------------------------------------------------------------------------------------------
Protect Patient Health            Security Risk       Required..........  0.................  Yes/No Statement.
 Information.                      Analysis.
Electronic Prescribing..........  e-Prescribing **..  Required..........  0.................  Numerator/
                                                                                               Denominator.
Patient Electronic Access.......  Provide Patient     Required..........  Up to 10%.........  Numerator/
                                   Access.                                                     Denominator.
                                  Patient-Specific    Not Required......  Up to 10%.........  Numerator/
                                   Education.                                                  Denominator.
Coordination of Care Through      View, Download, or  Not Required......  Up to 10%.........  Numerator/
 Patient Engagement.               Transmit (VDT).                                             Denominator.
                                  Secure Messaging..  Not Required......  Up to 10%.........  Numerator/
                                                                                               Denominator.
                                  Patient-Generated   Not Required......  Up to 10%.........  Numerator/
                                   Health Data.                                                Denominator.
Health Information Exchange.....  Send a Summary of   Required..........  Up to 10%.........  Numerator/
                                   Care **.                                                    Denominator.
                                  Request/Accept      Required..........  Up to 10%.........  Numerator/
                                   Summary of Care                                             Denominator.
                                   **.
                                  Clinical            Not Required......  Up to 10%.........  Numerator/
                                   Information                                                 Denominator.
                                   Reconciliation.
Public Health and Clinical Data   Immunization        Not Required......  0 or 10% *........  Yes/No Statement.
 Registry Reporting.               Registry
                                   Reporting.
                                  Syndromic           Not Required......  0 or 10%*.........  Yes/No Statement.
                                   Surveillance
                                   Reporting.
                                  Electronic Case     Not Required......  0 or 10%*.........  Yes/No Statement.
                                   Reporting.
                                  Public Health       Not Required......  0 or 10%*.........  Yes/No Statement.
                                   Registry
                                   Reporting.
                                  Clinical Data       Not Required......  0 or 10%*.........  Yes/No Statement.
                                   Registry
                                   Reporting.
----------------------------------------------------------------------------------------------------------------

[[Page 53677]]

 
                                                Bonus (up to 25%)
----------------------------------------------------------------------------------------------------------------
Report to one or more additional p5% bonusalth                            Yes/No Statement..
 agencies or clinical data registries beyond the one
 identified for the performance score.
Report improvement activities usin10% bonus.........                      Yes/No Statement..
Report using only 2015 Edition CEH10% bonus.........                      Based on measures
                                                                           submitted..
----------------------------------------------------------------------------------------------------------------
* A MIPS eligible clinician may earn 10 percent for each public health agency or clinical data registry to which
  the clinician reports, up to a maximum of 10 percent under the performance score.
** Exclusions are available for these measures.


  Table 8--2018 Performance Period Advancing Care Information Performance Category Scoring Methodology for 2018
                          Advancing Care Information Transition Objectives and Measures
----------------------------------------------------------------------------------------------------------------
                                    2018 advancing       Required/not
 2018 advancing care information   care information    required for base   Performance score       Reporting
      transition objective        transition measure      score (50%)         (Up to 90%)         requirement
----------------------------------------------------------------------------------------------------------------
Protect Patient Health            Security Risk       Required..........  0.................  Yes/No Statement.
 Information.                      Analysis.
Electronic Prescribing..........  E-Prescribing**...  Required..........  0.................  Numerator/
                                                                                               Denominator.
Patient Electronic Access.......  Provide Patient     Required..........  Up to 20%.........  Numerator/
                                   Access.                                                     Denominator.
                                  View, Download, or  Not Required......  Up to 10%.........  Numerator/
                                   Transmit (VDT).                                             Denominator.
Patient-Specific Education......  Patient-Specific    Not Required......  Up to 10%.........  Numerator/
                                   Education.                                                  Denominator.
Secure Messaging................  Secure Messaging..  Not Required......  Up to 10%.........  Numerator/
                                                                                               Denominator.
Health Information Exchange.....  Health              Required..........  Up to 20%.........  Numerator/
                                   Information**                                               Denominator.
                                   Exchange.
Medication Reconciliation.......  Medication          Not Required......  Up to 10%.........  Numerator/
                                   Reconciliation.                                             Denominator.
Public Health Reporting.........  Immunization        Not Required......  0 or 10%*.........  Yes/No Statement.
                                   Registry
                                   Reporting.
                                  Syndromic           Not Required......  0 or 10% *........  Yes/No Statement.
                                   Surveillance
                                   Reporting.
                                  Specialized         Not Required......  0 or 10% *........  Yes/No Statement.
                                   Registry
                                   Reporting.
----------------------------------------------------------------------------------------------------------------
                                                 Bonus up to 15%
----------------------------------------------------------------------------------------------------------------
Report to one or more additional public health agencies or clinical data  5% bonus..........  Yes/No Statement.
 registries beyond the one identified for the performance score.
Report improvement activities using CEHRT...............................  10% bonus.........  Yes/No Statement.
----------------------------------------------------------------------------------------------------------------
* A MIPS eligible clinician may earn 10% for each public health agency or clinical data registry to which the
  clinician reports, up to a maximum of 10% under the performance score.
** Exclusions are available for these measures.

    To facilitate readers in identifying the requirements of CEHRT for 
the Advancing Care Information Objectives and Measures, we are 
including the Table 9, which includes the 2015 Edition and 2014 Edition 
certification criteria required to meet the objectives and measures.

    Table 9--Advancing Care Information and Advancing Care Information Transition Objectives and Measures and
                                Certification Criteria for 2014 and 2015 Editions
----------------------------------------------------------------------------------------------------------------
             Objective                     Measure                2015 Edition                2014 Edition
----------------------------------------------------------------------------------------------------------------
Protect Patient Health Information  Security Risk          The requirements are a      The requirements are
                                     Analysis.              part of CEHRT specific to   included in the Base EHR
                                                            each certification          Definition.
                                                            criterion.
Electronic Prescribing............  e-Prescribing........  Sec.   170.315(b)(3)        Sec.   170.314(b)(3)
                                                            (Electronic Prescribing).   (Electronic
                                                            Sec.   170.315(a)(10)       Prescribing). Sec.
                                                            (Drug-Formulary and         170.314(a)(10) (Drug-
                                                            Preferred Drug List         Formulary and Preferred
                                                            checks.                     Drug List checks.

[[Page 53678]]

 
Patient Electronic Access.........  Provide Patient        Sec.   170.315(e)(1)        Sec.   170.314(e)(1)
                                     Access.                (View, Download, and        (View, Download, and
                                                            Transmit to 3rd Party).     Transmit to 3rd Party).
                                                            Sec.   170.315(g)(7)
                                                            (Application Access--
                                                            Patient Selection). Sec.
                                                             170.315(g)(8)
                                                            (Application Access--Data
                                                            Category Request). Sec.
                                                            170.315(g)(9)
                                                            (Application Access--All
                                                            Data Request). The three
                                                            criteria combined are the
                                                            ``API'' certification
                                                            criteria.
Patient Electronic Access/Patient   Patient Specific       Sec.   170.315(a)(13)       Sec.   170.314(a)(13)
 Specific Education.                 Education.             (Patient-specific           (Patient-specific
                                                            Education Resources).       Education Resources).
Coordination of Care Through        View, Download, or     Sec.   170.315(e)(1)        Sec.   170.314(e)(1)
 Patient Engagement/Patient          Transmit (VDT).        (View, Download, and        (View, Download, and
 Electronic Access.                                         Transmit to 3rd Party).     Transmit to 3rd Party).
                                                            Sec.   170.315(g)(7)
                                                            (Application Access--
                                                            Patient Selection). Sec.
                                                             170.315(g)(8)
                                                            (Application Access--Data
                                                            Category Request). Sec.
                                                            170.315(g)(9)
                                                            (Application Access--All
                                                            Data Request) The three
                                                            criteria combined are the
                                                            ``API'' certification
                                                            criteria.
Coordination of Care Through        Secure Messaging.....  Sec.   170.315(e)(2)        Sec.   170.314(e)(3)
 Patient Engagement.                                        (Secure Messaging).         (Secure Messaging).
Coordination of Care Through        Patient-Generated      Sec.   170.315(e)(3)        N/A.
 Patient Engagement.                 Health Data.           (Patient Health
                                                            Information Capture)
                                                            Supports meeting the
                                                            measure, but is NOT
                                                            required to be used to
                                                            meet the measure. The
                                                            certification criterion
                                                            is part of the CEHRT
                                                            definition beginning in
                                                            2018.
Health Information Exchange.......  Send a Summary of      Sec.   170.315(b)(1)        Sec.   170.314(b)(2)
                                     Care.                  (Transitions of Care).      (Transitions of Care-
                                                                                        Create and Transmit
                                                                                        Transition of Care/
                                                                                        Referral Summaries or
                                                                                        Sec.   170.314(b)(8)
                                                                                        (Optional--Transitions
                                                                                        of Care).
Health Information Exchange.......  Request/Accept         Sec.   170.315(b)(1)        Sec.   170.314(b)(1)
                                     Summary of Care.       (Transitions of Care).      (Transitions of Care-
                                                                                        Receive, Display and
                                                                                        Incorporate Transition
                                                                                        of Care/Referral
                                                                                        Summaries or Sec.
                                                                                        170.314(b)(8) (Optional--
                                                                                        Transitions of Care).
Health Information Exchange.......  Clinical Information   Sec.   170.315(b)(2)        Sec.   170.314(b)(4)
                                     Reconciliation.        (Clinical Information       (Clinical Information
                                                            Reconciliation and          Reconciliation or Sec.
                                                            Incorporation).             170.314(b)(9) (Optional--
                                                                                        Clinical Information
                                                                                        Reconciliation and
                                                                                        Incorporation).
Health Information Exchange.......  Health Information     N/A.......................  Sec.   170.314(b)(2)
                                     Exchange.                                          (Transitions of Care-
                                                                                        Create and Transmit
                                                                                        Transition of Care/
                                                                                        Referral Summaries or
                                                                                        Sec.   170.314(b)(8)
                                                                                        (Optional--Transitions
                                                                                        of Care).
Medication Reconciliation.........  Medication             N/A.......................  Sec.   170.314(b)(4)
                                     Reconciliation.                                    (Clinical Information
                                                                                        Reconciliation) or Sec.
                                                                                         170.314(b)(9)
                                                                                        (Optional-- Clinical
                                                                                        Information
                                                                                        Reconciliation and
                                                                                        Incorporation).
Public Health and Clinical Data     Immunization Registry  Sec.   170.315(f)(1)        N/A.
 Registry Reporting/Public Health    Reporting.             (Transmission to
 Reporting.                                                 Immunization Registries).
Public Health and Clinical Data     Syndromic              Sec.   170.315(f)(2)        Sec.   170.314(f)(3)
 Registry Reporting/Public Health    Surveillance           (Transmission to Public     (Transmission to Public
 Reporting.                          Reporting.             Health Agencies--           Health Agencies--
                                                            Syndromic Surveillance)     Syndromic Surveillance)
                                                            Urgent Care Setting Only.   or Sec.   170.314(f)(7)
                                                                                        (Optional-Ambulatory
                                                                                        Setting Only--
                                                                                        Transmission to Public
                                                                                        Health Agencies--
                                                                                        Syndromic Surveillance).
Public Health and Clinical Data     Electronic Case        Sec.   170.315(f)(5)        N/A.
 Registry Reporting.                 Reporting.             (Transmission to Public
                                                            Health Agencies--
                                                            Electronic Case
                                                            Reporting).
Public Health and Clinical Data     Public Health          EPs may choose one or more  Sec.   170.314(f)(5)
 Registry Reporting.                 Registry Reporting.    of the following: Sec.      (Optional--Ambulatory
                                                            170.315(f)(4)               Setting Only--Cancer
                                                            (Transmission to Cancer     Case Information and
                                                            Registries). Sec.           Sec.   170.314(f)(6)
                                                            170.315(f)(7)               (Optional--Ambulatory
                                                            (Transmission to Public     Setting Only--
                                                            Health Agencies--Health     Transmission to Cancer
                                                            Care Surveys).              Registries).
Public Health and Clinical Data     Clinical Data          No 2015 Edition health IT   N/A.
 Registry Reporting.                 Registry Reporting.    certification criteria at
                                                            this time.

[[Page 53679]]

 
Public Health Reporting...........  Specialized Registry   N/A.......................  Sec.   170.314(f)(5)
                                     Reporting.                                         (Optional--Ambulatory
                                                                                        Setting Only--Cancer
                                                                                        Case Information) and
                                                                                        Sec.   170.314(f)(6)
                                                                                        (Optional-- Ambulatory
                                                                                        Setting Only--
                                                                                        Transmission to Cancer
                                                                                        Registries).
----------------------------------------------------------------------------------------------------------------

(c) Exclusions
    We proposed to add exclusions to the measures associated with the 
Health Information Exchange and Electronic Prescribing Objectives 
required for the base score, as described below. We proposed these 
exclusions would apply beginning with the CY 2017 performance period.
Proposed Exclusion for the E-Prescribing Objective and Measure
Advancing Care Information Objective and Measure
    Objective: Electronic Prescribing.
    Objective: Generate and transmit permissible prescriptions 
electronically.
    E-Prescribing Measure: At least one permissible prescription 
written by the MIPS eligible clinician is queried for a drug formulary 
and transmitted electronically using CEHRT.
    Proposed Exclusion: Any MIPS eligible clinician who writes fewer 
than 100 permissible prescriptions during the performance period.
2017 and 2018 Advancing Care Information Transition Objective and 
Measure
    Objective: Electronic Prescribing.
    Objective: MIPS eligible clinicians must generate and transmit 
permissible prescriptions electronically.
    E-Prescribing Measure: At least one permissible prescription 
written by the MIPS eligible clinician is queried for a drug formulary 
and transmitted electronically using CEHRT.
    Proposed Exclusion: Any MIPS eligible clinician who writes fewer 
than 100 permissible prescriptions during the performance period.
Proposed Exclusion for the Health Information Exchange Objective and 
Measures Advancing Care Information Objective and Measures
    Objective: Health Information Exchange.
    Objective: The MIPS eligible clinician provides a summary of care 
record when transitioning or referring their patient to another setting 
of care, receives or retrieves a summary of care record upon the 
receipt of a transition or referral or upon the first patient encounter 
with a new patient, and incorporates summary of care information from 
other health care clinician into their EHR using the functions of 
CEHRT.
    Send a Summary of Care Measure: For at least one transition of care 
or referral, the MIPS eligible clinician that transitions or refers 
their patient to another setting of care or health care clinician (1) 
creates a summary of care record using CEHRT; and (2) electronically 
exchanges the summary of care record.
    We note that we finalized our proposal to replace ``health care 
clinician'' with ``health care provider'' in the objective and measure.
    Proposed Exclusion: Any MIPS eligible clinician who transfers a 
patient to another setting or refers a patient is fewer than 100 times 
during the performance period.
    Request/Accept Summary of Care Measure: For at least one transition 
of care or referral received or patient encounter in which the MIPS 
eligible clinician has never before encountered the patient, the MIPS 
eligible clinician receives or retrieves and incorporates into the 
patient's record an electronic summary of care document.
    Proposed Exclusion: Any MIPS eligible clinician who receives 
transitions of care or referrals or has patient encounters in which the 
MIPS eligible clinician has never before encountered the patient fewer 
than 100 times during the performance period.
2017 and 2018 Advancing Care Information Transition Objective and 
Measures
    Objective: Health Information Exchange.
    Objective: The MIPS eligible clinician provides a summary of care 
record when transitioning or referring their patient to another setting 
of care, receives or retrieves a summary of care record upon the 
receipt of a transition or referral or upon the first patient encounter 
with a new patient, and incorporates summary of care information from 
other health care clinicians into their EHR using the functions of 
CEHRT.
    Health Information Exchange Measure: The MIPS eligible clinician 
that transitions or refers their patient to another setting of care or 
health care clinician (1) uses CEHRT to create a summary of care 
record; and (2) electronically transmits such summary to a receiving 
health care clinician for at least one transition of care or referral.
    We note that we finalized our proposal to replace ``health care 
clinician'' with ``health care provider'' in the objective and measure.
    Proposed Exclusion: Any MIPS eligible clinician who transfers a 
patient to another setting or refers a patient fewer than 100 times 
during the performance period.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: Commenters overwhelmingly supported the addition of 
exclusions for the Electronic Prescribing, Health Information Exchange, 
Send a Summary of Care, and Request/Accept Summary of Care Measures.
    Response: We appreciate the support of the proposed modifications, 
and for the reasons discussed in the proposed rule, agree that it is 
appropriate to establish these exclusions.
    Comment: One commenter supported establishing exclusions but 
recommended that the thresholds be set at fewer than 200 instead of 
fewer than 100 as proposed.
    Response: We disagree. We proposed the exclusions because these 
measures may be outside a MIPS eligible clinician's licensing authority 
or outside their scope of practice. By claiming the exclusion, the MIPS 
eligible clinician is indicating that the measure is inapplicable to 
them, because they have few patients or insufficient number of actions 
that would allow calculation of the measure. We proposed the fewer than 
100 threshold to align with the exclusions for these measures that were 
established for the Medicare and Medicaid EHR Incentive Programs. We 
believe that the threshold of fewer than 100 will enable MIPS eligible 
clinicians

[[Page 53680]]

who do not prescribe, or transfer or refer patients or rarely do so to 
claim the exclusion(s) and still fulfill the base score of the 
advancing care information performance category. We believe a threshold 
of 200 is too high, and believe that a MIPS eligible clinician who is 
prescribing, transferring or referring more than 100 times during the 
performance period is taking the actions described in the measures 
often enough to be able to report on the measures for at least one 
patient to fulfil the base score requirement.
    Comment: One commenter was pleased to see CMS's intent to establish 
an exclusion for the e-Prescribing Measure. They stated that as doctors 
of chiropractic are statutorily prohibited in most states from 
prescribing medication, this measure created a great deal of concern 
over the last year that doctors of chiropractic would be adversely 
affected by not reporting this measure.
    Response: We did not intend to disadvantage chiropractors or other 
types of clinicians who may be prohibited by law from prescribing 
medication. We are establishing this exclusion for the e-Prescribing 
Measure beginning with the 2017 performance period.
    Comment: One commenter requested that if a MIPS eligible clinician 
claims an exclusion for the base score for the Health Information 
Exchange Measure, they should also be able to claim an exclusion for 
the performance score for this measure so their total advancing care 
information points are not adversely affected.
    Response: We disagree. MIPS eligible clinicians have many options 
to earn performance score points. If a measure is not applicable to a 
clinician, they have the flexibility to select other performance score 
measures on which to report.
    Comment: One commenter asked if these exclusions are available if 
reporting as a group.
    Response: Yes, MIPS eligible clinicians may claim the exclusion if 
they are reporting as a group. In the CY 2017 Quality Payment Program 
final rule (81 FR 77215), we stated that the group will need to 
aggregate data for all the individual MIPS eligible clinicians within 
the group for whom they have data in CEHRT, and if an individual MIP 
eligible clinician meets the criteria to exclude a measure, their data 
can be excluded from the calculation of that particular measure only.
    Comment: One commenter questioned whether clinicians who qualify to 
exclude these measures will be allowed to report on the measures. The 
commenter encouraged CMS to consider allowing these clinicians to 
exclude or to attest to the measures as they stated that both measures 
are key objectives in the advancing care information performance 
category and also stated that it will be beneficial to encourage 
clinicians to attest to both measures, even if they qualify to exclude 
them.
    Response: MIPS eligible clinicians may claim these exclusions if 
they qualify, although they do not have to claim the exclusions and may 
report on the measures if they choose to do so.
    Comment: One commenter requested that for the Request/Accept a 
Summary of Care Measure, that the exclusion be more closely tied to the 
logic for the denominator of that measure, so that the exclusion is 
specified in terms of new patients for whom a summary of care is 
available.
    Response: While we understand this concern, we disagree that the 
exclusion should be limited to new patients. While we believe the 
exclusion should include instances where the MIPS eligible clinician 
has never before encountered the patient, we do not want to limit it to 
just those instances.
    Final Action: After consideration of the public comments, we are 
finalizing these proposals as proposed. We note that the exclusions 
apply beginning with the 2017 performance period.
(7) Additional Considerations
(a) 21st Century Cures Act
    As we noted in the CY 2017 Quality Payment Program final rule (81 
FR 77238), section 101(b)(1)(A) of the MACRA amended section 
1848(a)(7)(A) of the Act to sunset the meaningful use payment 
adjustment at the end of CY 2018. Section 1848(a)(7) of the Act 
includes certain statutory exceptions to the meaningful use payment 
adjustment under section 1848(a)(7)(A) of the Act. Specifically, 
section 1848(a)(7)(D) of the Act exempts hospital-based EPs from the 
application of the payment adjustment under section 1848(a)(7)(A) of 
the Act. In addition, section 1848(a)(7)(B) of the Act provides that 
the Secretary may, on a case-by-case basis, exempt an EP from the 
application of the payment adjustment under section 1848(a)(7)(A) of 
the Act if the Secretary determines, subject to annual renewal, that 
compliance with the requirement for being a meaningful EHR user would 
result in a significant hardship, such as in the case of an EP who 
practices in a rural area without sufficient internet access. The last 
sentence of section 1848(a)(7)(B) of the Act also provides that in no 
case may an exemption be granted under subparagraph (B) for more than 5 
years. The MACRA did not maintain these statutory exceptions for the 
advancing care information performance category of the MIPS. Thus, we 
had previously stated that the provisions under sections 1848(a)(7)(B) 
and (D) of the Act are limited to the meaningful use payment adjustment 
under section 1848(a)(7)(A) of the Act and do not apply in the context 
of the MIPS.
    Following the publication of the CY 2017 Quality Payment Program 
final rule, the 21st Century Cures Act (Pub. L. 114-255) was enacted on 
December 13, 2016. Section 4002(b)(1)(B) of the 21st Century Cures Act 
amended section 1848(o)(2)(D) of the Act to state that the provisions 
of sections 1848(a)(7)(B) and (D) of the Act shall apply to assessments 
of MIPS eligible clinicians under section 1848(q) of the Act with 
respect to the performance category described in subsection 
(q)(2)(A)(iv) (the advancing care information performance category) in 
an appropriate manner which may be similar to the manner in which such 
provisions apply with respect to the meaningful use payment adjustment 
made under section 1848(a)(7)(A) of the Act. As a result of this 
legislative change, we believe that the general exceptions described 
under sections 1848(a)(7)(B) and (D) of the Act are applicable under 
the MIPS program. We included the proposals described below to 
implement these provisions as applied to assessments of MIPS eligible 
clinicians under section 1848(q) of the Act with respect to the 
advancing care information performance category.
(i) MIPS Eligible Clinicians Facing a Significant Hardship
    In the CY 2017 Quality Payment Program final rule (81 FR 77240 
through 77243), we recognized that there may not be sufficient measures 
applicable and available under the advancing care information 
performance category to MIPS eligible clinicians facing a significant 
hardship, such as those who lack sufficient internet connectivity, face 
extreme and uncontrollable circumstances, lack control over the 
availability of CEHRT, or do not have face-to-face interactions with 
patients. We relied on section 1848(q)(5)(F) of the Act to establish a 
final policy to assign a zero percent weighting to the advancing care 
information performance category in the final score if there are not 
sufficient measures and activities applicable and available to MIPS 
eligible clinicians within the categories of significant hardship noted 
above (81 FR 77243). Additionally, under the final policy (81 FR 
77243), we did not impose a limitation on the total number of MIPS 
payment years for which the advancing

[[Page 53681]]

care information performance category could be weighted at zero 
percent, in contrast with the 5-year limitation on significant hardship 
exceptions under the Medicare EHR Incentive Program as required by 
section 1848(a)(7)(B) of the Act.
    We did not propose substantive changes to this policy; however, as 
a result of the changes in the law made by the 21st Century Cures Act 
discussed above, we will not rely on section 1848(q)(5)(F) of the Act 
and instead proposed to use the authority in the last sentence of 
section 1848(o)(2)(D) of the Act for significant hardship exceptions 
under the advancing care information performance category under MIPS. 
Section 1848(o)(2)(D) of the Act, as amended by section 4002(b)(1)(B) 
of the 21st Century Cures Act, states in part that the provisions of 
section 1848(a)(7)(B) of the Act shall apply to assessments of MIPS 
eligible clinicians with respect to the advancing care information 
performance category in an appropriate manner which may be similar to 
the manner in which such provisions apply with respect to the payment 
adjustment made under section 1848(a)(7)(A) of the Act. We would assign 
a zero percent weighting to the advancing care information performance 
category in the MIPS final score for a MIPS payment year for MIPS 
eligible clinicians who successfully demonstrate a significant hardship 
through the application process. We would use the same categories of 
significant hardship and application process as established in the CY 
2017 Quality Payment Program final rule (81 FR 77240-77243). We would 
automatically reweight the advancing care information performance 
category to zero percent for a MIPS eligible clinician who lacks face-
to-face patient interaction and is classified as a non-patient facing 
MIPS eligible clinician without requiring an application. If a MIPS 
eligible clinician submits an application for a significant hardship 
exception or is classified as a non-patient facing MIPS eligible 
clinician, but also reports on the measures specified for the advancing 
care information performance category, they would be scored on the 
advancing care information performance category like all other MIPS 
eligible clinicians, and the category would be given the weighting 
prescribed by section 1848(q)(5)(E) of the Act regardless of the MIPS 
eligible clinician's score.
    As required under section 1848(a)(7)(B) of the Act, eligible 
professionals were not granted significant hardship exceptions for the 
payment adjustments under the Medicare EHR Incentive Program for more 
than 5 years. We proposed not to apply the 5-year limitation under 
section 1848(a)(7)(B) of the Act to significant hardship exceptions for 
the advancing care information performance category under MIPS.
    We solicited comments on the proposed use of the authority provided 
in the 21st Century Cures Act in section 1848(o)(2)(D) of the Act as it 
relates to application of significant hardship exceptions under MIPS 
and the proposal not to apply a 5-year limit to such exceptions.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: Many commenters supported our proposal not to apply the 5-
year limit for significant hardship exceptions. Some commenters stated 
that the 5-year limit was arbitrary and should be eliminated. Other 
commenters stated that the issue causing the hardship may not be 
rectified within a 5-year period, and thus, could create undue burdens 
on the clinicians in the future. Assigning a zero percent weighting to 
the advancing care information performance category for those who 
successfully demonstrate a significant hardship through the application 
process would provide significant relief.
    Response: We thank commenters for their support and agree it is 
possible a clinician could experience a hardship for more than 5 years.
    Comment: One commenter suggested that under the EHR Incentive 
Program, a significant hardship exception would apply even if a health 
care provider attested to meaningful use. They requested that we not 
penalize eligible clinicians who choose to submit data, and to apply 
the exception if they qualify.
    Response: We disagree. Under the EHR Incentive Program, if a health 
care provider submits a request for or is otherwise granted a 
significant hardship exception, and also successfully attests to 
meaningful use, we would consider that provider to be a meaningful EHR 
user based on its attestation and thus would not apply the exception. 
Under MIPS, we continue to believe that this approach is warranted. If 
a MIPS eligible clinician chooses to submit data for the advancing care 
information performance category, they will be scored. As we explained 
in the CY 2017 Quality Payment Program final rule (81 FR 77241), we 
believe there may not be sufficient advancing care information measures 
applicable and available to MIPS eligible clinicians who experience a 
significant hardship, such as insufficient internet connectivity, 
extreme and uncontrollable circumstances, lack of control over the 
availability of CEHRT, and lack of face-to-face patient interaction. We 
believe that the submission of data indicates that there are sufficient 
measures applicable and available for the MIPS eligible clinician, and 
therefore, the significant hardship exception is not necessary.
    Comment: One commenter recommended that CMS outline more specific 
criteria for hardship exceptions because allowing too many exceptions 
could hinder adoption of the changes required to create a more 
efficient, value focused health care system. They suggested that 
hardship exceptions only be available for unusual and unique clinician 
circumstances.
    Response: While we understand the concern expressed in this 
comment, we decline to adopt narrower criteria for significant hardship 
exceptions at this time. We understand that the transition to MIPS has 
created challenges for MIPS eligible clinicians, and we believe the 
significant hardship exception policy we proposed would encourage more 
clinicians to participate successfully in the other performance 
categories of MIPS.
    Comment: One commenter questioned the proposed requirement to 
reapply for a hardship exception on an annual basis and recommended 
that exceptions should be granted for 2 years.
    Response: We disagree and believe it is appropriate to limit a 
hardship exception to 1 year. We want to encourage MIPS eligible 
clinicians to adopt and use CEHRT and allowing multi-year exceptions 
would not accomplish that goal. We believe that granting hardship 
exceptions for 1 year at a time will enable clinicians to work harder 
to successfully participate in the advancing care information 
performance category while knowing that there may be the possibility of 
receiving a significant hardship exception if it is needed and they 
qualify. Furthermore we have created a streamlined mechanism for the 
submission of Quality Payment Program Hardship Exception Applications. 
Applications that are submitted are reviewed on a rolling basis.
    Comment: One commenter expressed concern about occupational 
therapists participating in MIPS as they were never eligible for the 
EHR Incentive Program. They stated that many clinicians in solo or very 
small therapy practices cannot afford the expense of purchasing an EHR 
documentation system. For this reason, the commenter requested that in 
CY 2018 and future

[[Page 53682]]

years CMS grant them exceptions. Further, they recommended that CMS 
dedicate staff to engage therapists in an effort to provide consistent 
and targeted education regarding CEHRT requirements, applicable 
electronic measures, and other new criteria so they may be successful 
under the advancing care information performance category.
    Response: We appreciate this comment and point out that under 
section 1848(q)(1)(C)(i)(II) of the Act, additional eligible clinicians 
such as occupational therapists could be considered MIPS eligible 
clinicians starting in the third year of the program. If we decide to 
add additional clinician types to the definition of a MIPS eligible 
clinician, it would be proposed and finalized through notice and 
comment rulemaking. We would support these clinicians and help them to 
become successful program participants.
    Comment: One commenter expressed concern over the proposal to not 
apply the 5-year limit to significant hardship exceptions. They stated 
that although it is important to acknowledge circumstances outside of a 
clinician's control, it does not seem necessary to grant these hardship 
exceptions in perpetuity.
    Response: While we appreciate this comment, we disagree. We believe 
that a variety of circumstances may arise, and the application of the 
5-year limit could unfairly disadvantage MIPS eligible clinicians whose 
circumstances warrant a hardship exception. For example, a MIPS 
eligible clinician may lack control over the availability of CEHRT and 
apply annually for and receive a hardship exception for 5 years. If 
their practice is later significantly affected by a natural disaster, 
such as a hurricane, they would be unable to receive a hardship 
exception due to the 5-year limit, even though they would otherwise 
qualify for the exception.
    Comment: Commenters recommended adding additional hardship 
exception categories such as those eligible for Social Security 
benefits, those who have changed specialty taxonomy, those who practice 
in Tribal health care facilities and those who are solo practitioners.
    Response: While we appreciate the suggestions, we are declining to 
adopt these suggestions at this time. We will monitor performance on 
the advancing care information performance category to determine if 
additional hardship exception categories are appropriate. As we have 
previously stated, we do not believe that it is appropriate to reweight 
this category solely on the basis of a MIPS eligible clinicians' age or 
Social Security status, and believe that while other factors such as 
the lack of access to CEHRT or unforeseen environmental circumstances 
may constitute a significant hardship, the age of an MIPS eligible 
clinician alone or the preference to not obtain CEHRT does not. We note 
that solo practitioners would be included in the small practice 
significant hardship that we proposed at 82 FR 30076 so a separate 
hardship exception category for them is unnecessary.
    Final Action: After consideration of the comments we received, we 
are finalizing our policy as proposed.
(ii) Significant Hardship Exception for MIPS Eligible Clinicians in 
Small Practices
    Section 1848(q)(2)(B)(iii) of the Act requires the Secretary to 
give consideration to the circumstances of small practices (consisting 
of 15 or fewer professionals) and practices located in rural areas and 
geographic HPSAs in establishing improvement activities under MIPS. In 
the CY 2017 Quality Payment Program final rule (81 FR 77187 through 
77188), we finalized that for MIPS eligible clinicians and groups that 
are in small practices or located in rural areas, or geographic health 
professional shortage areas (HPSAs), to achieve full credit under the 
improvement activities category, one high-weighted or two medium-
weighted improvement activities are required.
    While there is no corresponding statutory provision for the 
advancing care information performance category, we believe that 
special consideration should also be available for MIPS eligible 
clinicians in small practices. We proposed a significant hardship 
exception for the advancing care information performance category for 
MIPS eligible clinicians who are in small practices, under the 
authority in section 1848(o)(2)(D) of the Act, as amended by section 
4002(b)(1)(B) of the 21st Century Cures Act (see discussion of the 
statutory authority for significant hardship exceptions in section 
II.C.6.f.(7)(ii) of the proposed rule). We proposed that this hardship 
exception would be available to MIPS eligible clinicians in small 
practices as defined under Sec.  414.1305. We proposed in section 
II.C.1.e. of the proposed rule, that CMS would make eligibility 
determinations regarding the size of small practices for performance 
periods occurring in 2018 and future years. We proposed to reweight the 
advancing care information performance category to zero percent of the 
MIPS final score for MIPS eligible clinicians who qualify for this 
hardship exception. We proposed this exception would be available 
beginning with the 2018 performance period and 2020 MIPS payment year. 
We proposed a MIPS eligible clinician seeking to qualify for this 
exception would submit an application in the form and manner specified 
by us by December 31st of the performance period or a later date 
specified by us. We also proposed MIPS eligible clinicians seeking this 
exception must demonstrate in the application that there are 
overwhelming barriers that prevent the MIPS eligible clinician from 
complying with the requirements for the advancing care information 
performance category. In accordance with section 1848(a)(7)(B) of the 
Act, the exception would be subject to annual renewal. Under the 
proposal in section II.C.6.f.(7)(a) of the proposed rule, the 5-year 
limitation under section 1848(a)(7)(B) of the Act would not apply to 
this significant hardship exception for MIPS eligible clinicians in 
small practices.
    While we would be making this significant hardship exception 
available to small practices in particular, we are considering whether 
other categories or types of clinicians might similarly require an 
exception. We solicited comment on what those categories or types are, 
why such an exception is required, and any data available to support 
the necessity of the exception. We noted that supporting data would be 
particularly helpful to our consideration of whether any additional 
exceptions would be appropriate.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: Commenters supported and appreciated the significant 
hardship exception that we proposed for MIPS eligible clinicians in 
small practices. Many commenters stated that there are a number of 
administrative and financial barriers that small practices would be 
required to negotiate in order to be successful in the advancing care 
information performance category.
    Response: We appreciate this support and believe it is appropriate 
to provide a significant hardship exception for MIPS eligible 
clinicians in small practices, in part due to the barriers identified 
by the commenters.
    Comment: One commenter disagreed with our proposal to establish a 
significant hardship exception for small practices. They stated that 
while there are challenges that clinicians in small practices face in 
implementing HIT, well-implemented HIT can add to a practice's capacity 
to deliver high quality care. For a practice with limited support 
staff, HIT can make it easier for clinicians to communicate with their 
patients, know in real time about the

[[Page 53683]]

care their patients are receiving at other practices, and actively 
manage the population health of their entire patient panel. They 
recommended that CMS help and encourage small practices to adopt and 
meaningfully use HIT, rather than sending the message that HIT is a 
``significant hardship'' that small practices should consider avoiding.
    Response: While we agree that the use of HIT has many benefits and 
ideally all MIPS eligible clinicians would utilize CEHRT, we understand 
it may not be feasible at this time for all practices. We hope that 
over time more and more practices will realize the benefits of CEHRT 
and interoperability with other clinicians and successfully adopt and 
utilize CEHRT. We do offer no-cost technical assistance to small 
practices through the Small, Underserved, and Rural Support initiative. 
To find your local Small, Underserved, and Rural Support organization 
please review the Technical Assistance Resource Guide on qpp.cms.gov, 
or use the search feature on the ``Small Practices'' Web page.
    Comment: Some commenters recommended other significant hardship 
exceptions such as for MIPS eligible clinicians practicing in medically 
underserved areas or MIPS eligible clinicians caring for a medically 
underserved population.
    Response: We are adopting several policies in this final rule with 
comment period that will reduce its impact on small and solo practices, 
including the creation of a hardship exception for MIPS eligible 
clinicians in small practices. We will be monitoring participation in 
MIPS and in the advancing care information performance category to 
determine if it is appropriate to establish additional hardship 
exceptions for clinicians in medically underserved areas and those who 
serve underserved populations. Further, this final rule with comment 
period's provisions are designed to encourage participation, 
incentivize continuous improvement, and move participants on a glide 
path to improved health care delivery in the Quality Payment Program.
    Comment: One commenter applauded CMS for proposing a hardship 
exception for small practices and requested that CMS provide more 
assistance to small practices that are willing to try to integrate 
information technology. They stated the invaluable assistance provided 
by the Regional Extension Centers for the Medicare and Medicare EHR 
Incentive Programs.
    Response: We do offer no-cost technical assistance to small 
practices through the Small, Underserved, and Rural Support initiative. 
This initiative is comprised of 11 professional and experienced 
organizations who are ready to help clinicians in small practices and 
rural areas prepare for and participate in the Quality Payment Program. 
We try to ensure that priority is given to small practices in rural 
locations, health professional shortage areas, and medically 
underserved areas. The organizations within the Small, Underserved, and 
Rural Support initiative can help clinicians determine if they are 
included in the program, choose whether they will participate 
individually or as a part of a group, determine their data submission 
method, identify appropriate measures and activities, and much more. To 
find your local Small, Underserved, and Rural Support organization 
please review the Technical Assistance Resource Guide on qpp.cms.gov, 
or use the search feature on the ``Small Practices'' Web page.
    Comment: Commenters questioned the requirement that MIPS eligible 
clinicians must demonstrate that there are overwhelming barriers that 
prevent them from complying with the requirements of the advancing care 
information performance category. They believe that such a requirement 
is not clear or concise, and detracts from program goals.
    Response: We understand these concerns; however, we believe that 
adopting and implementing CEHRT may not be a significant hardship for 
some small practices. For small practices experiencing a significant 
hardship, we proposed that they demonstrate, through their application, 
there are overwhelming barriers to complying with the requirements of 
the advancing care information performance category. We do not 
anticipate any additional burden associated with this requirement as we 
do not intend to require documentation of the overwhelming barriers. 
While we sincerely hope that MIPS eligible clinicians will be able to 
successfully report for the advancing care information performance 
category, we understand that small practices do have challenges that 
would benefit from added flexibility and time to adopt CEHRT.
    Comment: One commenter recommended expanding the definition of 
small practice so that it is not limited to practices with 15 or fewer 
clinicians. Another suggested a threshold of 18 clinicians.
    Response: While we understand the concern that the proposed 
definition could be under-inclusive, we are not modifying our proposal. 
We believe it is more important to reduce burden by having one 
definition of small practice for the MIPS program and choose to align 
the definition for purposes of this significant hardship exception with 
the definition under Sec.  414.1305.
    Comment: Some commenters stated that practices located in rural 
areas often experience many of the same barriers as small practices 
such as financial limitations and workforce shortages. The effects of 
these challenges are magnified because clinicians in rural areas serve 
as critical access points for care and often provide a safety net for 
vulnerable populations. Commenters stated that CMS includes both small 
practices and practices located in rural areas in many of its policies 
proposed to reduce burden, including the low-volume threshold and 
flexibility under the improvement activities category, but neglected to 
include practices located in rural areas in its hardship exception 
proposal for advancing care information. Commenters believed this was 
an oversight and urged CMS to create a hardship exception for 
clinicians that practice in rural areas. Others requested that CMS 
modify the proposed advancing care information hardship exception so 
that it applies to both small practices and practices located in rural 
areas. They also requested that CMS make this an automatic exemption so 
as not to add to the burden of clinicians in these practices by 
requiring them to demonstrate ``overwhelming barriers'' to compliance. 
To recognize more advanced practices, the commenter suggested that CMS 
could offer an opt-in that would allow small and rural practices that 
believe they are prepared to participate in the advancing care 
information performance category to do so.
    Response: We disagree that the hardship exception should be 
``automatic'' for small practices because we believe many small 
practices will be able to successfully report on the advancing care 
information performance category. For those small practice that wish to 
apply for this significant hardship exception, we have simplified the 
application process for hardship exceptions under MIPS as compared with 
the process available for the Medicare EHR Incentive Program. We will 
be monitoring participation in MIPS and in the advancing care 
information performance category to determine if it is appropriate to 
establish an additional hardship exception for clinicians practicing in 
rural areas in future rulemaking.
    Final Action: After consideration of the comments that we received, 
we are adopting our policy as proposed.

[[Page 53684]]

(iii) Hospital-Based MIPS Eligible Clinicians
    In the CY 2017 Quality Payment Program final rule (81 FR 77238 
through 77240), we defined a hospital-based MIPS eligible clinician 
under Sec.  414.1305 as a MIPS eligible clinician who furnishes 75 
percent or more of his or her covered professional services in sites of 
service identified by the Place of Service (POS) codes used in the 
HIPAA standard transaction as an inpatient hospital (POS 21), on-campus 
outpatient hospital (POS 22), or emergency room (POS 23) setting, based 
on claims for a period prior to the performance period as specified by 
CMS. We discussed our assumption that MIPS eligible clinicians who are 
determined hospital-based do not have sufficient advancing care 
information measures applicable to them, and we established a policy to 
reweight the advancing care information performance category to zero 
percent of the MIPS final score for the MIPS payment year in accordance 
with section 1848(q)(5)(F) of the Act (81 FR 77240).
    We did not propose substantive changes to this policy; however, as 
a result of the changes in the law made by the 21st Century Cures Act 
discussed above, we will not rely on section 1848(q)(5)(F) of the Act 
and instead proposed to use the authority in the last sentence of 
section 1848(o)(2)(D) of the Act for exceptions for hospital-based MIPS 
eligible clinicians under the advancing care information performance 
category. Section 1848(o)(2)(D) of the Act, as amended by section 
4002(b)(1)(B) of the 21st Century Cures Act, states in part that the 
provisions of section 1848(a)(7)(D) of the Act shall apply to 
assessments of MIPS eligible clinicians with respect to the advancing 
care information performance category in an appropriate manner which 
may be similar to the manner in which such provisions apply with 
respect to the payment adjustment made under section 1848(a)(7)(A) of 
the Act. We would assign a zero percent weighting to the advancing care 
information performance category in the MIPS final score for a MIPS 
payment year for hospital-based MIPS eligible clinicians as previously 
defined. A hospital-based MIPS eligible clinician would have the option 
to report the advancing care information measures for the performance 
period for the MIPS payment year for which they are determined 
hospital-based. However, if a MIPS eligible clinician who is determined 
hospital-based chooses to report on the advancing care information 
measures, they would be scored on the advancing care information 
performance category like all other MIPS eligible clinicians, and the 
category would be given the weighting prescribed by section 
1848(q)(5)(E) of the Act regardless of their score.
    We proposed to amend Sec.  414.1380(c)(1) and (2) of the regulation 
text to reflect this proposal.
    We requested comments on the proposed use of the authority provided 
in the 21st Century Cures Act in section 1848(o)(2)(D) of the Act as it 
relates to hospital-based MIPS eligible clinicians.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: One commenter recommended that this policy be effective as 
soon as possible.
    Response: We note that this policy would apply beginning with the 
first year of the Quality Payment Program, the 2017 performance period. 
We did not propose substantive changes to our existing policy for 
hospital-based MIPS eligible clinicians; rather, we proposed to rely on 
different statutory authority for the policy.
    Comment: The majority of commenters supported our proposal. Many 
stated that there are insufficient measures applicable and available to 
hospital-based MIPS eligible clinicians for the advancing care 
information performance category of MIPS.
    Response: We appreciate the support of commenters. We continue to 
believe that hospital-based MIPS eligible clinicians may not have 
control over the decisions that the hospital makes regarding the use of 
health IT and CEHRT. These MIPS eligible clinicians therefore may have 
no control over the type of CEHRT available, the way that the 
technology is implemented and used, or whether the hospital continually 
invests in the technology to ensure it is compliant with ONC 
certification criteria.
    Comment: Commenters urged us to be transparent and give MIPS 
eligible clinicians timely notice well in advance of the start of the 
performance period whether or not they are hospital-based and therefore 
not required to participate in the advancing care information 
performance category.
    Response: We agree. We want to inform MIPS eligible clinicians as 
soon as possible of their hospital-based status. Unfortunately, in this 
first year of the Quality Payment Program, we were unable to provide 
this information as soon as we had hoped. It became available in August 
2017, but for future performance periods it is expected that the 
information will be available sooner.
    Comment: Commenters stated that under the current hospital-based 
group definition, if less than 100 percent of the clinicians in a group 
are considered hospital-based, then the group is expected to submit 
advancing care information performance category data for the portion of 
clinicians who are not hospital-based, even if that is only a small 
percentage. Commenters stated they believe the intent of the group 
reporting option is to ease the administrative burden of reporting on 
behalf of an entire group. Commenters also stated it is unreasonable to 
expect a group, where the majority of clinicians are hospital-based, to 
parse out the minority of clinicians who are not hospital-based and to 
report their advancing care information performance category data to 
CMS.
    They suggested that CMS adopt a policy whereby if the simple 
majority of the group's clinicians meet the definition of hospital-
based, as individuals, then the group as a whole would be exempt from 
the advancing care information performance category.
    Response: We disagree and note that the group would not be expected 
to parse out any data, but would instead report the aggregated data of 
the entire group (hospital-based MIPS eligible clinicians included), 
thus, there would be no additional burden to prepare the data for 
reporting. We direct readers to the discussion of Scoring for MIPS 
Eligible Clinicians in Groups in section II.6.f(c)(7) of this final 
rule with comment period.
    Final Action: After consideration of the comments we received, we 
are finalizing our policy as proposed. We will amend Sec.  
414.1380(c)(1) and (2) of the regulation text to reflect this policy.
(iv) Ambulatory Surgical Center (ASC)--Based MIPS Eligible Clinicians
    Section 16003 of the 21st Century Cures Act amended section 
1848(a)(7)(D) of the Act to provide that no payment adjustment may be 
made under section 1848(a)(7)(A) of the Act for 2017 and 2018 in the 
case of an eligible professional who furnishes substantially all of his 
or her covered professional services in an ambulatory surgical center 
(ASC). Section 1848(a)(7)(D)(iii) of the Act provides that 
determinations of whether an eligible professional is ASC-based may be 
made based on the site of service as defined by the Secretary or an 
attestation, but shall be made without regard to any employment or 
billing arrangement between the eligible professional and any other 
supplier or provider of services. Section 1848(a)(7)(D)(iv) of the Act 
provides that

[[Page 53685]]

the ASC-based exception shall no longer apply as of the first year that 
begins more than 3 years after the date on which the Secretary 
determines, through notice and comment rulemaking, that CEHRT 
applicable to the ASC setting is available.
    Under section 1848(o)(2)(D) of the Act, as amended by section 
4002(b)(1)(B) of the 21st Century Cures Act, the ASC-based provisions 
of section 1848(a)(7)(D) of the Act shall apply to assessments of MIPS 
eligible clinicians under section 1848(q) of the Act with respect to 
the advancing care information performance category in an appropriate 
manner which may be similar to the manner in which such provisions 
apply with respect to the payment adjustment made under section 
1848(a)(7)(A) of the Act. We believe the proposals for ASC-based MIPS 
eligible clinicians are an appropriate application of the provisions of 
section 1848(a)(7)(D) of the Act to MIPS eligible clinicians. Under the 
Medicare EHR Incentive Program an approved hardship exception exempted 
an EP from the payment adjustment. We believe that weighting the 
advancing care information performance category to zero percent is 
similar in effect to an exemption from the requirements of that 
performance category.
    To align with our hospital-based MIPS eligible clinician policy, we 
proposed to define at Sec.  414.1305 an ASC-based MIPS eligible 
clinician as a MIPS eligible clinician who furnishes 75 percent or more 
of his or her covered professional services in sites of service 
identified by the Place of Service (POS) code 24 used in the HIPAA 
standard transaction based on claims for a period prior to the 
performance period as specified by us. We requested comments on this 
proposal and solicit comments as to whether other POS codes should be 
used to identify a MIPS eligible clinician's ASC-based status or if an 
alternative methodology should be used. We noted that the ASC-based 
determination will be made independent of the hospital-based 
determination.
    To determine a MIPS eligible clinician's ASC-based status, we 
proposed to use claims with dates of service between September 1 of the 
calendar year 2 years preceding the performance period through August 
31 of the calendar year preceding the performance period, but in the 
event it is not operationally feasible to use claims from this time 
period, we would use a 12-month period as close as practicable to this 
time period. We proposed this timeline to allow us to notify MIPS 
eligible clinicians of their ASC-based status prior to the start of the 
performance period and to align with the hospital-based MIPS eligible 
clinician determination period. For the 2019 MIPS payment year, we 
would not be able to notify MIPS eligible clinicians of their ASC-based 
status until after the final rule with comment period is published, 
which we anticipate would be later in 2017. We expect that we would 
provide this notification through QPP.cms.gov.
    For MIPS eligible clinicians who we determine are ASC-based, we 
proposed to assign a zero percent weighting to the advancing care 
information performance category in the MIPS final score for the MIPS 
payment year. However, if a MIPS eligible clinician who is determined 
ASC-based chooses to report on the Advancing Care Information Measures 
or the Advancing Care Information Transition Measures, if applicable, 
for the performance period for the MIPS payment year for which they are 
determined ASC-based, we proposed they would be scored on the advancing 
care information performance category like all other MIPS eligible 
clinicians, and the performance category would be given the weighting 
prescribed by section 1848(q)(5)(E) of the Act regardless of their 
advancing care information performance category score.
    We proposed these ASC-based policies would apply beginning with the 
2017 performance period/2019 MIPS payment year.
    We proposed to amend Sec.  414.1380(c)(1) and (2) of the regulation 
text to reflect these proposals.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: One commenter requested that the ASC-based MIPS eligible 
clinician determination be added to the hospital-based determination so 
that we would make a determination based on the sum of services 
performed in an ASC, inpatient hospital, emergency room and on-campus 
outpatient hospital as they believe that application is in line with 
congressional intent.
    Response: We disagree. We proposed that the ASC-based MIPS eligible 
clinician determination be made separately from the hospital-based 
determination because section 1848(a)(7)(D) of the Act, as amended by 
section 16003 of the 21st Century Cures Act, distinguishes between 
hospital-based and ASC-based clinicians, and continue to believe this 
approach is most consistent with the statute. However, we note that the 
commenter incorrectly described our hospital-based policy by stating we 
determine a clinician's status based on one setting. To determine if a 
MIPS eligible clinician is hospital-based, we currently consider the 
percentage of covered professional services furnished in POS codes 21, 
22, and 23 collectively and not separately.
    Comment: One commenter urged CMS to allow ASC-based MIPS eligible 
clinicians the ability to apply for a significant hardship exception to 
reweight their advancing care information performance category score 
even if their ASC-based status changes subsequent to the deadline to 
apply for the significant hardship exception. The commenter stated that 
these clinicians likely would not have control over the CEHRT in their 
practice and should have their advancing care information performance 
category score reweighted to zero.
    Response: We note that we will make the determination about whether 
a MIPS eligible clinician is ASC-based by looking claims with dates of 
service between September 1 of the calendar year 2 years preceding the 
performance period through August 31 of the calendar year preceding the 
performance period. It is our intent to make determinations prior to 
the close of the submission period for significant hardship exceptions.
    Final Action: After consideration of the comments we received, we 
are finalizing our policy as proposed. We are amending Sec.  414.1305 
and Sec.  414.1380(c)(1) and (2) to reflect this policy.
(v) Exception for MIPS Eligible Clinicians Using Decertified EHR 
Technology
    Section 4002(b)(1)(A) of the 21st Century Cures Act amended section 
1848(a)(7)(B) of the Act to provide that the Secretary shall exempt an 
eligible professional from the application of the payment adjustment 
under section 1848(a)(7)(A) of the Act with respect to a year, subject 
to annual renewal, if the Secretary determines that compliance with the 
requirement for being a meaningful EHR user is not possible because the 
CEHRT used by such professional has been decertified under ONC's Health 
IT Certification Program. Section 1848(o)(2)(D) of the Act, as amended 
by section 4002(b)(1)(B) of the 21st Century Cures Act, states in part 
that the provisions of section 1848(a)(7)(B) of the Act shall apply to 
assessments of MIPS eligible clinicians with respect to the advancing 
care information performance category in an appropriate manner which 
may be similar to the manner in which such provisions apply with 
respect to the

[[Page 53686]]

payment adjustment made under section 1848(a)(7)(A) of the Act.
    We proposed that a MIPS eligible clinician may demonstrate through 
an application process that reporting on the measures specified for the 
advancing care information performance category is not possible because 
the CEHRT used by the MIPS eligible clinician has been decertified 
under ONC's Health IT Certification Program. We proposed that if the 
MIPS eligible clinician's demonstration is successful and an exception 
is granted, we would assign a zero percent weighting to the advancing 
care information performance category in the MIPS final score for the 
MIPS payment year. In accordance with section 1848(a)(7)(B) of the Act, 
the exception would be subject to annual renewal, and in no case may a 
MIPS eligible clinician be granted an exception for more than 5 years. 
We proposed this exception would be available beginning with the CY 
2018 performance period and the 2020 MIPS payment year.
    We proposed that a MIPS eligible clinician may qualify for this 
exception if their CEHRT was decertified either during the performance 
period for the MIPS payment year or during the calendar year preceding 
the performance period for the MIPS payment year. In addition, we 
proposed that the MIPS eligible clinician must demonstrate in their 
application and through supporting documentation if available that the 
MIPS eligible clinician made a good faith effort to adopt and implement 
another CEHRT in advance of the performance period. We proposed a MIPS 
eligible clinician seeking to qualify for this exception would submit 
an application in the form and manner specified by us by December 31st 
of the performance period, or a later date specified by us.
    We proposed to amend Sec.  414.1380(c)(1) and (2) of the regulation 
text to reflect these proposals.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: Commenters supported the creation of a hardship exception 
for clinicians whose EHR becomes decertified. One commenter stated that 
the proposal was a sensible approach that supports clinicians who 
encounter serious issues with EHR technology that are outside their 
control.
    Response: We appreciate the support of commenters for this 
proposal.
    Comment: One commenter recommended that clinicians be held harmless 
in an automated fashion if there CEHRT becomes decertified. The 
commenter expressed concern that the terms ``made a good faith effort'' 
and ``through supporting documentation'' are vague and requested 
further guidance.
    Response: While we understand the concern, MIPS eligible clinicians 
frequently change EHR vendors, and we would not know that they are 
using a product that has been decertified unless they notified CMS. We 
have a fairly simple system through which MIPS eligible clinicians may 
apply for an exception. Documentation does not need to be submitted 
with the application, but MIPS eligible clinicians should retain 
documentation that supports their request for an exception based on 
decertified EHR technology.
    Comment: One commenter recommended that we communicate the 
availability of this hardship exception for clinicians who learn that 
their CEHRT does not conform to the ONC certification requirements.
    Response: We plan to add this decertification exception category to 
the Quality Payment Program Hardship Exception Application on 
qpp.cms.gov.
    Comment: One commenter urged CMS to use at least a 2-year exemption 
period and allow clinicians to seek additional time if necessary before 
they are subject to the advancing care information performance category 
reporting requirements. A few commenters stated it was more appropriate 
to allow a 3-year exemption period because of the time necessary to 
acquire a new system, move data, redesign workflows and train clinical 
and administrative staffs.
    Response: All exceptions for the advancing care information 
performance category are approved for 1 year only, and the exception 
application would be subject to annual renewal. We stated that MIPS 
eligible clinician may qualify for this exception if their CEHRT was 
decertified either during the performance period for the MIPS payment 
year or during the calendar year preceding the performance period for 
the MIPS payment year. If the transition to a new CEHRT takes much 
longer than expected for reasons beyond the clinician's control, they 
could potentially apply for a significant hardship exception based on 
extreme and uncontrollable circumstances.
    Comment: Several commenters recommended expanding this proposal to 
include CEHRT that has its certification suspended. Commenters 
indicated a suspension would occur only when ONC identifies that CEHRT 
poses a ``potential risk to public health or safety''.
    Response: While we understand these concerns, section 1848(a)(7)(B) 
of the Act, as amended by section 4002(b)(1)(A) of the 21st Century 
Cures Act, provides authority for an exception in the event of 
decertification, not suspension of certification.
    Final Action: After consideration of the comments we received, we 
are finalizing our policy as proposed. We are amending Sec.  
414.1380(c)(1) and (2) of the regulation text to reflect this policy.
(b) Hospital-Based MIPS Eligible Clinicians
    In the CY 2017 Quality Payment Program final rule (81 FR 77238 
through 77240, we defined a hospital-based MIPS eligible clinician as a 
MIPS eligible clinician who furnishes 75 percent or more of his or her 
covered professional services in sites of services identified by the 
Place of Service (POS) codes used in the HIPAA standard transaction as 
an inpatient hospital (POS 21), on campus outpatient hospital (POS 22) 
or emergency room (POS 23) setting, based on claims for a period prior 
to the performance period as specified by CMS.
    We proposed to modify our policy to include covered professional 
services furnished by MIPS eligible clinicians in an off-campus-
outpatient hospital (POS 19) in the definition of hospital-based MIPS 
eligible clinician. POS 19 was developed in 2015 in order to capture 
the numerous physicians that are paid for a portion of their services 
in an ``off campus-outpatient hospital'' versus an on campus-outpatient 
hospital, (POS 22). We also believe that these MIPS eligible clinicians 
would not typically have control of the development and maintenance of 
their EHR systems, just like those who bill using POS 22. We proposed 
to add POS 19 to our existing definition of a hospital-based MIPS 
eligible clinician beginning with the performance period in 2018.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: Commenters expressed their support for the addition of 
off-campus-outpatient hospital (POS 19) to the definition of hospital-
based.
    Response: We appreciate the support and believe it is appropriate 
to add off-campus-outpatient hospital (POS 19) in the definition of 
hospital-based MIPS eligible clinician because this setting is similar 
to the on-campus outpatient hospital setting in that the MIPS eligible 
clinicians lack control over CEHRT.
    Comment: A few commenters urged CMS to automatically reweight the 
advancing care information performance category for clinicians who 
predominantly practice in settings such as Comprehensive Inpatient

[[Page 53687]]

Rehabilitation Facility (IRF; POS 61) and Skilled Nursing Facility 
(SNF: POS 31) as clinicians who practice in these settings will 
struggle to meet advancing care information requirements much like 
inpatient hospital-based eligible clinicians. For example, they may not 
have control over the decisions that the facilities make regarding the 
use of health IT and CEHRT, and requirements under the Protect Patient 
Health Information Objective to conduct a security risk analysis would 
rely on the actions of the facilities, rather than the actions of the 
MIPS eligible clinicians.
    Response: We thank the commenters for bringing these settings to 
our attention, and although we did not include them in our proposals, 
we will monitor MIPS participation of clinicians who practice in these 
settings to determine if they are able to meet the requirements of the 
advancing care information performance category.
    Final Action: After consideration of the public comments, we are 
adopting our proposal as proposed.
(c) Scoring for MIPS Eligible Clinicians in Groups
    In any of the situations described in the sections above, we would 
assign a zero percent weighting to the advancing care information 
performance category in the MIPS final score for the MIPS payment year 
if the MIPS eligible clinician meets certain specified requirements for 
this weighting. We noted that these MIPS eligible clinicians may choose 
to submit Advancing Care Information Measures or the Advancing Care 
Information Transition Measures, if applicable; however, if they choose 
to report, they will be scored on the advancing care information 
performance category like all other MIPS eligible clinicians and the 
performance category will be given the weighting prescribed by section 
1848(q)(5)(E) of the Act regardless of their advancing care information 
performance category score. This policy includes MIPS eligible 
clinicians choosing to report as part of a group or part of a virtual 
group.
    Groups as defined at Sec.  414.1310(e)(1) are required to aggregate 
their performance data across the TIN in order for their performance to 
be assessed as a group (81 FR 77058). Additionally, groups that elect 
to have their performance assessed as a group will be assessed as a 
group across all four MIPS performance categories. By reporting as part 
of a group, MIPS eligible clinicians are subscribing to the data 
reporting and scoring requirements of the group. We noted that the data 
submission criteria for groups reporting advancing care information 
performance category described in the CY 2017 Quality Payment Program 
final rule (81 FR 77215) state that group data should be aggregated for 
all MIPS eligible clinicians within the group. This includes those MIPS 
eligible clinicians who may qualify for a zero percent weighting of the 
advancing care information performance category due to the 
circumstances as described above, such as a significant hardship or 
other type of exception, hospital-based or ASC-based status, or certain 
types of non-physician practitioners (NPs, PAs, CNSs, and CRNAs). If 
these MIPS eligible clinicians report as part of a group or virtual 
group, they will be scored on the advancing care information 
performance category like all other MIPS eligible clinicians and the 
performance category will be given the weighting prescribed by section 
1848(q)(5)(E) of the Act regardless of the group's advancing care 
information performance category score.
    The following is a summary of the public comments received and our 
responses:
    Comment: One commenter urged CMS not to finalize this policy and 
instead to reweight the advancing care information category to zero 
percent for any group or virtual group in which the majority of 
individual clinicians would be exempt from scoring in that category. 
Another commenter suggested that groups should have the option to 
include or to not include data from non-patient facing and hospital-
based MIPS eligible clinicians in their aggregated advancing care 
information performance category data.
    Response: We did not propose any changes to our policy related to 
MIPS eligible clinicians in groups. We were simply restating the policy 
finalized for groups reporting data for the advancing care information 
performance category as described in the CY 2017 Quality Payment 
Program final rule (81 FR 77215) that group data should be aggregated 
for all MIPS eligible clinicians within the group. This includes those 
MIPS eligible clinicians who may qualify for a zero percent weighting 
of the advancing care information performance category based on a 
significant hardship or other type of exception, hospital-based or ASC-
based status, or certain types of non-physician practitioners (NPs, 
PAs, CNSs, and CRNAs). Our policy is 100 percent of the MIPS eligible 
clinicians in the group must qualify for a zero percent weighting in 
order for the advancing care information performance category to be 
reweighted in the final score.
    Comment: One commenter requested clarification as to how the 
advancing care information performance category of MIPS applies to 
group reporting. Specifically, the commenter stated that CMS' 
regulations and guidance are unclear as to whether it is permissible 
for a MIPS eligible clinician who participates in group reporting to 
not utilize CEHRT without disqualifying the entire group from 
attempting to report successfully on the advancing care information 
performance category. Another commenter asked if groups are able to 
report their advancing care information data by aggregating data for 
the entire TIN and including a denominator value only for the patients 
who were seen in a location with the use of CEHRT, or if the whole 
group would receive a zero for the advancing care information 
performance category because not all MIPS eligible clinicians in the 
group use CEHRT.
    Response: In the CY 2017 Quality Payment Program final rule (81 FR 
77215), we stated that the group will need to aggregate data for all 
the individual MIPS eligible clinicians within the group for whom they 
have data in CEHRT. The group should submit the data that they have in 
CEHRT and exclude data not collected from a non-certified EHR system. 
While we do not expect that every MIPS eligible clinician in the group 
will have access to CEHRT, or that every measure will apply to every 
clinician in the group, only those data contained in CEHRT should be 
reported for the advancing care information performance category.
    We will take these comments into consideration and may address the 
issues raised in future rulemaking.
(d) Timeline for Submission of Reweighting Applications
    In the CY 2017 Quality Payment Program final rule (81 FR 77240-
77243), we established the timeline for the submission of applications 
to reweight the advancing care information performance category in the 
MIPS final score to align with the data submission timeline for MIPS. 
We established that all applications for reweighting the advancing care 
information performance category be submitted by the MIPS eligible 
clinician or designated group representative in the form and manner 
specified by us. All applications may be submitted on a rolling basis, 
but must be received by us no later than the close of the submission 
period for the relevant performance period, or a later date specified 
by us. An application would need to be submitted annually to be 
considered for reweighting each year.

[[Page 53688]]

    The Quality Payment Program Exception Application will be used to 
apply for the following exceptions: Insufficient Internet Connectivity; 
Extreme and Uncontrollable Circumstances; Lack of Control over the 
Availability of CEHRT; Decertification of CEHRT; and Small Practice.
    We proposed to change the submission deadline for the application 
as we believe that aligning the data submission deadline with the 
reweighting application deadline could disadvantage MIPS eligible 
clinicians. We proposed to change the submission deadline for the CY 
2017 performance period to December 31, 2017, or a later date specified 
by us. We believe this change would help MIPS eligible clinicians by 
allowing them to learn whether their application is approved prior to 
the data submission deadline for the CY 2017 performance period, March 
31, 2018. We noted that if a MIPS eligible clinician submits data for 
the advancing care information performance category after an 
application has been submitted, the data would be scored, the 
application would be considered voided and the advancing care 
information performance category would not be reweighted.
    We further proposed that the submission deadline for the 2018 
performance period will be December 31, 2018, or a later date as 
specified by us. We believe this would help MIPS eligible clinicians by 
allowing them to learn whether their application is approved prior to 
the data submission deadline for the CY 2018 performance period, March 
31, 2019.
    The following is a summary of the public comments received on these 
proposals and our responses:
    Comment: One commenter requested that MIPS eligible clinicians be 
able to submit applications throughout the performance period and did 
not support the change to the application deadline. Another commenter 
suggested that MIPS eligible clinicians should be able to submit their 
applications throughout the performance period and receive a timely 
response from CMS.
    Response: We agree that MIPS eligible clinicians should be able to 
submit applications throughout the performance period. Under our 
proposal, MIPS eligible clinicians could submit applications anytime 
during CY 2017, which is the performance period. We believe that if the 
application submission period is open during the data submission 
period, MIPS eligible clinicians may not know whether their application 
is approved prior to the data submission period, and thus we proposed 
to change the application submission deadline to align with the end of 
the performance period.
    Comment: Commenters supported the change in the application 
submission deadline because it will reduce the reporting burden for 
those who are approved for a hardship exception.
    Response: We appreciate the support for our proposal.
    Comment: One commenter recommended that the submission deadline for 
hardship exceptions be changed to July 31, 2018 as they stated that the 
inclusion of the phrase ``or at a later date specified by us'' 
indicates that CMS acknowledges that the December 31st deadline may not 
be appropriate.
    Response: We disagree. We believe that it is appropriate to align 
the submission period for hardship exception applications with the 
performance period so that MIPS eligible clinicians will know whether 
their application was approved prior to the MIPS data submission 
deadline.
    Final Action: After consideration of the public comments, we are 
adopting our policy as proposed. We note that the submission of Quality 
Payment Program Hardship Exception Applications began during the 2017 
performance period (in August 2017) and will close at the end of the 
calendar year 2017.
g. APM Scoring Standard for MIPS Eligible Clinicians in MIPS APMs
(1) Overview
    Under section 1848(q)(1)(C)(ii)(1) of the Act, Qualifying APM 
Participants (QPs) are not MIPS eligible clinicians and are thus 
excluded from MIPS reporting requirements and payment adjustments. 
Similarly, under section 1848(q)(1)(c)(ii)(II) of the Act, Partial 
Qualifying APM Participants (Partial QPs) are also not MIPS eligible 
clinicians unless they opt to report and be scored under MIPS. All 
other MIPS eligible clinicians, including those participating in MIPS 
APMs, are subject to MIPS reporting requirements and payment 
adjustments unless they are excluded on another basis such as being 
newly enrolled in Medicare or not exceeding the low volume threshold.
    In the CY 2017 Quality Payment Program final rule, we finalized the 
APM scoring standard, which is designed to reduce reporting burden for 
participants in certain APMs by minimizing the need for them to make 
duplicative data submissions for both MIPS and their respective APMs 
(81 FR 77246 through 77269, 77543). We also sought to ensure that MIPS 
eligible clinicians in APM Entities that participate in certain types 
of APMs that assess their participants on quality and cost are assessed 
as consistently as possible across MIPS and their respective APMs. 
Given that many APMs already assess their participants on cost and 
quality of care and require engagement in certain improvement 
activities, we believe that without the APM scoring standard, 
misalignments could be quite common between the evaluation of 
performance under the terms of the APM and evaluation of performance on 
measures and activities under MIPS.
    In the CY 2017 Quality Payment Program final rule, we identified 
the types of APMs for which the APM scoring standard would apply as 
MIPS APMs (81 FR 77249). We finalized at Sec.  414.1370(b) that to be a 
MIPS APM, an APM must satisfy the following criteria: (1) APM Entities 
participate in the APM under an agreement with CMS or by law or 
regulation; (2) the APM requires that APM Entities include at least one 
MIPS eligible clinician on a Participation List; (3) the APM bases 
payment incentives on performance (either at the APM Entity or eligible 
clinician level) on cost/utilization and quality measures; and (4) the 
APM is not either a new APM for which the first performance period 
begins after the first day of the MIPS performance period for the year 
or an APM in the final year of operation for which the APM scoring 
standard is impracticable. We specified that we will post the list of 
MIPS APMs prior to the first day of the MIPS performance period for 
each year, though we expect that any new models would likely be 
announced 2 or more months before the start of the performance period 
for a year (81 FR 77250). We finalized in our regulations at Sec.  
414.1370(b) that for a new APM to be a MIPS APM, its first performance 
period must start on or before the first day of the MIPS performance 
period. A list of MIPS APMs is available at www.qpp.cms.gov.
    We also note that while it is possible to be both a MIPS APM and an 
Advanced APM, the criteria for the two are distinct, and a 
determination that an APM is an Advanced APM does not guarantee that it 
will be a MIPS APM and vice versa. We refer eligible clinicians to our 
Web site, qpp.cms.gov, for more information about participating in MIPS 
APMs and Advanced APMs.
    We established in the regulations at Sec.  414.1370(c) that the 
MIPS performance period under Sec.  414.1320 of our regulations applies 
for the APM scoring standard.
    We finalized that under section Sec.  414.1370(f) of our 
regulations, for the APM scoring standard, MIPS eligible clinicians 
will be scored at the APM

[[Page 53689]]

Entity group level, and each MIPS eligible clinician will receive the 
APM Entity group's final score. The MIPS payment adjustment is applied 
at the TIN/NPI level for each of the MIPS eligible clinicians in the 
APM Entity. The MIPS final score is comprised of the four MIPS 
performance category scores, as described in our regulation at Sec.  
414.1370(g): Quality, cost, improvement activities, and advancing care 
information. Both the Medicare Shared Savings Program and Next 
Generation ACO Model are MIPS APMs for the 2017 performance period. For 
these two MIPS APMs, in accordance with our regulations at Sec.  
414.1370(h), the MIPS performance category scores are weighted as 
follows: Quality at 50 percent; cost at zero percent; improvement 
activities at 20 percent; and advancing care information at 30 percent 
of the final score. For all other MIPS APMs for the 2017 performance 
period, quality and cost are each weighted at zero percent, improvement 
activities at 25 percent, and advancing care information at 75 percent 
of the final score.
    In the CY 2018 Quality Payment Program proposed rule, for the APM 
scoring standard, we proposed to: Amend Sec.  414.1370(e) to add an APM 
Entity group assessment date for MIPS eligible clinicians in full TIN 
APMs; continue to weight the cost performance category at zero and, in 
alignment with that proposal, to not take improvement into account for 
the cost performance category for 2020 and subsequent years; add the 
CAHPS for ACOs survey to the list of Shared Savings Program and Next 
Generation ACO Model quality measures that are used to calculate the 
MIPS APM quality performance category score beginning with the 2018 
performance period; define ``Other MIPS APMs'' under Sec.  414.1305; 
establish a separate MIPS APM list of quality measures for each Other 
MIPS APM and use that list for scoring in the quality performance 
category; calculate the MIPS quality performance category score for 
Other MIPS APMs using the APM-specific quality measures and score only 
those measures that are tied to payment as described under the terms of 
the APM, are available for scoring near the close of the MIPS 
submission period, have a minimum of 20 cases available for reporting 
and have an available benchmark; and add scoring for quality 
improvement to the MIPS APM quality performance category for all MIPS 
APMs beginning in 2018. We also proposed a quality scoring methodology 
for Other MIPS APMs beginning in the 2018 MIPS performance period and 
described the scoring methodology for quality improvement for Other 
MIPS APMs. We proposed to align the MIPS performance category weights 
for Other MIPS APMs with those used for Web Interface reporter APMs 
under the APM scoring standard; and proposed policies to address 
situations where a MIPS eligible clinician qualifies for reweighting to 
zero percent in the advancing care information performance category. We 
also proposed, beginning with the 2018 performance period, to provide 
MIPS eligible clinicians scored using the APM scoring standard with 
performance feedback as specified under section 1848(q)(12) of the Act 
for the quality, advancing care information, and improvement activities 
performance categories to the extent data are available (82 FR 30080 
through 30091). We discuss these final policies in this section of this 
final rule with comment period.
    In reviewing these proposals, we reminded readers that the APM 
scoring standard is built upon regular MIPS but provides for special 
policies to address the unique circumstances of MIPS eligible 
clinicians who are in APM Entities participating in MIPS APMs. For the 
cost, improvement activities, and advancing care information 
performance categories, unless a separate policy has been established 
or is being proposed for the APM scoring standard, the generally 
applicable MIPS policies would be applicable to the APM scoring 
standard. Additionally, unless we included a proposal to adopt a unique 
policy for the APM scoring standard, we proposed to adopt the same 
generally applicable MIPS policies proposed elsewhere in the CY 2018 
Quality Payment Program proposed rule and would treat the APM Entity 
group as the group for purposes of MIPS. For the quality performance 
category, however, the APM scoring standard we proposed is presented as 
a separate, unique standard, and therefore, generally applicable MIPS 
policies would not be applied to the quality performance category under 
the APM scoring standard unless specifically stated. We sought comment 
on whether there may be potential conflicts or inconsistencies between 
the generally applicable MIPS policies and those proposed under the APM 
scoring standard, particularly where these could impact our goals to 
reduce duplicative and potentially incongruous reporting requirements 
and performance evaluations that could undermine our ability to test or 
evaluate MIPS APMs, or whether certain generally applicable MIPS 
policies should be made explicitly applicable to the APM scoring 
standard.
(2) Assessment Dates for Inclusion of MIPS Eligible Clinicians in APM 
Entity Groups Under the APM Scoring Standard
    In the CY 2017 Quality Payment Program final rule, we specified in 
our regulations at Sec.  414.1370(e) that the APM Entity group for 
purposes of scoring under the APM scoring standard is determined in the 
manner prescribed at Sec.  414.1425(b)(1), which provides that eligible 
clinicians who are on a Participation List on at least one of three 
dates (March 31, June 30, and August 31) would be considered part of 
the APM Entity group. Under these regulations, MIPS eligible clinicians 
who are not on a Participation List on one of these three assessment 
dates are not scored under the APM scoring standard. Instead, they 
would need to submit data to MIPS through one of the MIPS data 
submission mechanisms and their performance would be assessed either as 
individual MIPS eligible clinicians or as a group according to the 
generally applicable MIPS criteria.
    We stated that we will continue to use the three assessment dates 
of March 31, June 30, and August 31 to identify MIPS eligible 
clinicians who are on an APM Entity's Participation List and determine 
the APM Entity group that is used for purposes of the APM scoring 
standard (82 FR 30081). In addition, beginning in the 2018 performance 
period, we proposed to add a fourth assessment date of December 31 to 
identify those MIPS eligible clinicians who participate in a full TIN 
APM. We proposed to define full TIN APM at Sec.  414.1305 to mean an 
APM where participation is determined at the TIN level, and all 
eligible clinicians who have assigned their billing rights to a 
participating TIN are therefore participating in the APM. An example of 
a full TIN APM is the Shared Savings Program, which requires all 
individuals and entities that have reassigned their right to receive 
Medicare payment to the TIN of an ACO participant to participate in the 
ACO and comply with the requirements of the Shared Savings Program.
    If an eligible clinician elects to reassign their billing rights to 
a TIN participating in a full TIN APM, the eligible clinician is 
necessarily participating in the full TIN APM. We proposed to add this 
fourth date of December 31 only for MIPS eligible clinicians in a full 
TIN APM, and only for purposes of applying the APM scoring standard. We 
did not propose to use this additional assessment date of December 31 
for purposes of QP

[[Page 53690]]

determinations. Therefore, we proposed to amend Sec.  414.1370(e) to 
identify the four assessment dates that would be used to identify the 
APM Entity group for purposes of the APM scoring standard, and to 
specify that the December 31 date would be used only to identify MIPS 
eligible clinicians on the APM Entity's Participation List for a MIPS 
APM that is a full TIN APM in order to add them to the APM Entity group 
that is scored under the APM scoring standard.
    We proposed to use this fourth assessment date of December 31 to 
extend the APM scoring standard to only those MIPS eligible clinicians 
participating in MIPS APMs that are full TIN APMs, ensuring that a MIPS 
eligible clinician who joins the full TIN APM between August 31 and 
December 31 in the performance period would be scored under the APM 
scoring standard. We considered proposing to use the fourth assessment 
date more broadly for all MIPS APMs. However, we noted that we believe 
that approach would have allowed MIPS eligible clinicians to 
inappropriately leverage the fourth assessment date to avoid reporting 
and scoring under the generally applicable MIPS scoring standard when 
they were part of the MIPS APM for only a very limited portion of the 
performance period. That is, for MIPS APMs that allow split TIN 
participation, we were concerned that it would be possible for MIPS 
eligible clinicians to briefly join a MIPS APM principally in order to 
benefit from the APM scoring standard, despite having limited 
opportunity to contribute to the APM Entity's performance in the MIPS 
APM. In contrast, we believe MIPS eligible clinicians would be less 
likely to join a full TIN APM principally to avail themselves of the 
APM scoring standard, since doing so would require either that the 
entire TIN join the MIPS APM or the administratively burdensome act of 
the MIPS eligible clinician reassigning their billing rights to the TIN 
of an entity participating in the full TIN APM.
    We will continue to use only the three dates of March 31, June 30, 
and August 31 to determine, based on Participation Lists, the MIPS 
eligible clinicians who participate in MIPS APMs that are not full TIN 
APMs. We sought comment on the proposed addition of the fourth date of 
December 31 to assess Participation Lists to identify MIPS eligible 
clinicians who participate in MIPS APMs that are full TIN APMs for 
purposes of the APM scoring standard.
    The following is a summary of the public comments received on this 
proposal and our responses:
    Comment: CMS received many comments in support of our proposal to 
add the December 31 snapshot date for full TIN APMs.
    Response: We thank commenters for their support of our proposal.
    Comment: Several commenters recommended that CMS make the fourth 
snapshot date policy retroactive so that it would apply for the 2017 
performance period.
    Response: We understand commenters' desire for the proposed policy 
to be applied retroactively to the 2017 performance period. However, in 
consideration of the requirement that we give the public notice of 
proposed changes and an opportunity to comment on them, we refrain from 
making retroactive regulatory changes unless there is specific and 
articulable authority and a reason why it is necessary and appropriate 
to do so; and we do not believe we have those in this situation.
    Comment: A few commenters requested a switch to 90 day assessment 
periods to determine participation in MIPS APMs.
    Response: We believe it is simplest to generally align the snapshot 
dates used for purposes of the APM scoring standard for MIPS APMs with 
those used to identify eligible clinicians in Advanced APMs for 
purposes of QP determinations.
    We anticipate that the current snapshot policy will identify the 
vast majority of MIPS eligible clinicians in MIPS APMs at the first 
snapshot, and then at subsequent snapshot dates will add those MIPS 
eligible clinicians who join a MIPS APM later in the year but still 
have a significant opportunity to contribute to the APM Entity's 
performance in the MIPS APM. As such, we believe this policy would more 
appropriately identify MIPS eligible clinicians for purposes of 
applying the APM scoring standard.
    Comment: A few commenters suggested adding the fourth snapshot date 
of December 31 for QP determinations as well.
    Response: We reiterate that we did not propose to add a fourth 
snapshot date of December 31 for QP determinations and we will not 
adopt a policy to do so in this rulemaking. We believe that the 
snapshot policy that we finalized in the CY 2017 Quality Payment 
Program final rule will allow for us to make QP determinations such 
that eligible clinicians, including those who fail to become QPs and 
who may need to report to MIPS, would know their QP status in advance 
of the end of the MIPS reporting period.
    Comment: A few commenters requested that CMS provide more 
information as to whether an eligible clinician is counted as a 
participant in a MIPS APM so that they know whether or not they are 
required to report to MIPS.
    Response: In the CY 2017 Quality Payment Program final rule, we 
stated that it is important to ensure that the appropriate parties are 
properly notified of their status for purposes of MIPS. We also stated 
that we would provide additional information on the format of such 
notifications and the data we will include as part of our public 
communications following the issuance of that final rule (81 FR 77450).
    Comment: Numerous comments recommended that CMS extend the fourth 
snapshot date to all MIPS APM participants.
    Response: In addition to avoiding duplicative or potentially 
inconsistent reporting requirements or incentives between MIPS and a 
MIPS APM, the APM scoring standard is intended to reduce the reporting 
burden of participants in MIPS APMs who have focused their practice 
transformation activities in the preceding performance period on the 
requirements of participation in the APM. As such, we believe it is 
appropriate to ensure that the APM scoring standard applies only for 
those who are genuinely committed to participation in MIPS APMs. By 
limiting applicability of the APM scoring standard to eligible 
clinicians who are on a MIPS APM's Participation List on one of the 
first three snapshot dates, we hope to minimize any potential 
opportunity for certain MIPS eligible clinicians to take inappropriate 
advantage of the APM scoring standard. Full TIN APMs, however, require 
that all individuals and entities billing through a TIN agree to 
participate in the APM in which the TIN is a participant. As a result, 
to avail themselves of the APM scoring standard, clinicians or entities 
would have to undergo the additional burden of joining a different 
billing TIN before starting their participation in the APM. Therefore, 
we believe that the risk of a MIPS eligible clinician inappropriately 
leveraging the APM scoring standard by joining an APM late in the year 
is significantly diminished in full-TIN APMs, and we are comfortable 
allowing for the use of the fourth snapshot date at the end of the 
performance period to identify the eligible clinicians participating in 
these APMs. We will continue to monitor this issue and may consider in 
future rulemaking whether there are other APM designs for which using a 
fourth

[[Page 53691]]

snapshot date would also be appropriate.
    Final Action: After considering public comments, we are finalizing 
our proposal to define full TIN APM at Sec.  414.1305 to mean an APM 
where participation is determined at the TIN level, and all eligible 
clinicians who have assigned their billing rights to a participating 
TIN are therefore participating in the APM. We are also finalizing our 
proposal to add a fourth date of December 31 only for MIPS eligible 
clinicians in a full TIN APM only for purposes of applying the APM 
scoring standard and we are finalizing our proposal to amend Sec.  
414.1370(e) to identify the four assessment dates that would be used to 
identify the APM Entity group for purposes of the APM scoring standard. 
We are also finalizing our proposal to specify that the December 31 
date would be used only to identify MIPS eligible clinicians on the APM 
Entity's Participation List for a MIPS APM that is a full TIN APM in 
order to add them to the APM Entity group that is scored under the APM 
scoring standard.
(3) Calculating MIPS APM Performance Category Scores
    In the CY 2017 Quality Payment Program final rule, we established a 
scoring standard for MIPS eligible clinicians participating in MIPS 
APMs to reduce participant reporting burden by reducing the need for 
MIPS eligible clinicians participating in these types of APMs to make 
duplicative data submissions for both MIPS and their respective APMs 
(81 FR 77246 through 77271). In accordance with section 
1848(q)(1)(D)(i) of the Act, we finalized a policy under which we 
assess the performance of a group of MIPS eligible clinicians in an APM 
Entity that participates in one or more MIPS APMs based on their 
collective performance as an APM Entity group, as defined in 
regulations at Sec.  414.1305.
    In addition to reducing reporting burden, we sought to ensure that 
MIPS eligible clinicians in MIPS APMs are not assessed in multiple ways 
on the same performance activities. Depending on the terms of the 
particular MIPS APM, we believe that misalignments could be common 
between the evaluation of performance on quality and cost under MIPS 
versus under the terms of the APM. We continue to believe that 
requiring MIPS eligible clinicians in MIPS APMs to submit data, be 
scored on measures, and be subject to payment adjustments that are not 
aligned between MIPS and a MIPS APM could potentially undermine the 
validity of testing or performance evaluation under the APM. We also 
believe imposition of MIPS reporting requirements would result in 
reporting activity that provides little or no added value to the 
assessment of MIPS eligible clinicians, and could confuse these 
eligible clinicians as to which CMS incentives should take priority 
over others in designing and implementing care improvement activities.
(a) Cost Performance Category
    In the CY 2017 Quality Payment Program final rule, for MIPS 
eligible clinicians participating in MIPS APMs, we used our authority 
to waive certain requirements under the statute to reduce the scoring 
weight for the cost performance category to zero (81 FR 77258, 77262, 
and 77266). For MIPS APMs authorized under section 1115A of the Act 
using our authority under section 1115A(d)(1) of the Act, we waived the 
requirement under section 1848(q)(5)(E)(i)(II) of the Act, which 
specifies the scoring weight for the cost performance category. Having 
reduced the cost performance category weight to zero, we further used 
our authority under section 1115A(d)(1) of the Act to waive the 
requirements under sections 1848(q)(2)(B)(ii) and 1848(q)(2)(A)(ii) of 
the Act to specify and use, respectively, cost measures in calculating 
the MIPS final score for MIPS eligible clinicians participating in MIPS 
APMs (81 FR 77261-77262; 81 FR 77265 through 77266). Similarly, for 
MIPS eligible clinicians participating in the Shared Savings Program, 
we used our authority under section 1899(f) of the Act to waive the 
same requirements of section 1848 of the Act for the MIPS cost 
performance category (81 FR 77257 through 77258). We finalized this 
policy because: (1) APM Entity groups are already subject to cost and 
utilization performance assessment under the MIPS APMs; (2) MIPS APMs 
usually measure cost in terms of total cost of care, which is a broader 
accountability standard that inherently encompasses the purpose of the 
claims-based measures that have relatively narrow clinical scopes, and 
MIPS APMs that do not measure cost in terms of total cost of care may 
depart entirely from MIPS measures; and (3) the beneficiary attribution 
methodologies differ for measuring cost under APMs and MIPS, leading to 
an unpredictable degree of overlap (for eligible clinicians and for 
CMS) between the sets of beneficiaries for which eligible clinicians 
would be responsible that would vary based on the unique APM Entity 
characteristics such as which and how many eligible clinicians comprise 
an APM Entity group. We believe that with an APM Entity's finite 
resources for engaging in efforts to improve quality and lower costs 
for a specified beneficiary population, measurement of the population 
identified through the APM must take priority in order to ensure that 
the goals and the model evaluation associated with the APM are as clear 
and free of confounding factors as possible. The potential for 
different, conflicting results across APMs and MIPS assessments may 
create uncertainty for MIPS eligible clinicians who are attempting to 
strategically transform their respective practices and succeed under 
the terms of the APM.
    We sought comment on our proposal to continue to waive the 
weighting of the cost performance category for the 2020 payment year 
forward (82 FR 30082). The following is a summary of the public 
comments we received on this proposal and our responses:
    Comment: Several commenters supported our proposal.
    Response: We thank commenters for their support of our proposal.
    Comment: One commenter requested that the cost performance category 
be scored for MIPS APMs to further incentivize efficient and 
appropriate care delivery.
    Response: We agree that encouraging efficient and appropriate care 
delivery is an important aim of MIPS. We also believe that the MIPS 
APMs specifically are working toward achieving this goal in diverse and 
innovative ways by basing participants' Medicare payment on their 
performance on cost/utilization and quality measures. Because 
participants in MIPS APMs are already scored and have payment based on 
their performance on cost/utilization measures under their respective 
APM, we continue to believe scoring of the cost performance category is 
unnecessary and could create conflicting incentives for participants in 
MIPS APMs if their MIPS payment adjustment is also based in part on 
their performance in the MIPS cost performance category.
    Comment: One commenter supported the reweighting of the cost 
performance category to zero, but requested that CMS provide 
performance feedback in the cost performance category to MIPS eligible 
clinicians in MIPS APMs.
    Response: We understand commenters' desire to have information on 
MIPS eligible clinicians' performance under the MIPS cost performance 
category, even if they are not scored on cost under the APM scoring 
standard. However, each MIPS APM's payment design is unique and 
distinct from MIPS. Comparing participants in these APMs to other

[[Page 53692]]

MIPS eligible clinicians may lead to misleading or not meaningful 
results. Because we are unable to provide accurate and meaningful 
feedback for the MIPS cost performance category for those MIPS eligible 
clinicians scored under the APM scoring standard, we will not be 
including it in the performance feedback. However, MIPS APMs may 
provide some level of feedback to their participants on cost/
utilization measure performance.
    Comment: One commenter suggested that CMS should score the cost 
performance category for MIPS APMs, but that CMS should first find a 
way to align episodes between MIPS and episode-based APMs.
    Response: Currently there is no way for us to align MIPS cost 
measures with episodes as defined within certain MIPS APMs because each 
of those MIPS APMs uniquely identifies the period of time over which 
performance is assessed and scored. For example, the Oncology Care 
Model has semi-annual performance periods, with 6-month episodes 
beginning on any day within a semi-annual performance period; initial 
reconciliation occurs after a performance period ends using a two month 
claims runout from the final day of the performance period, and 
subsequent ``true-up'' reconciliations capture additional claims runout 
after 8 and 14 months after the performance period ends. This MIPS APM 
uses unique methods of defining when performance is measured and scores 
calculated; attempting to align a model like the Oncology Care Model 
with other MIPS APMs or MIPS would require large-scale modifications to 
one or more initiatives that would undermine their design. Further, 
changing a MIPS APM's performance period could be burdensome and 
disruptive for health care providers participating in MIPS APMs. For 
these reasons, we do not believe it is advisable to change an APMs' 
episode timing or performance periods for MIPS purposes.
    Because of the innovative and unique nature of each MIPS APM and 
the need to maintain flexibility in designing and implementing them, we 
do not believe it would be appropriate to attempt to conform 
programmatic elements of APMs to MIPS.
    Final Action: After considering public comments, we are finalizing 
the proposal to continue to use our authority under sections 
1115A(d)(1) and 1899(f) of the Act to waive the requirements of the 
statute to reweight the cost performance category to zero for MIPS APMs 
for the 2020 payment year and subsequent payment years as proposed. We 
are codifying this policy at Sec.  414.1370(g)(2).
(i) Measuring Improvement in the Cost Performance Category
    In setting performance standards with respect to measures and 
activities in each MIPS performance category, section 1848(q)(3)(B) of 
the Act requires us to consider historical performance standards, 
improvement, and the opportunity for continued improvement. Section 
1848(q)(5)(D)(i)(I) of the Act requires us to introduce the measurement 
of improvement into performance scores in the cost performance category 
for MIPS eligible clinicians for the 2020 MIPS Payment Year if data 
sufficient to measure improvement are available. Section 
1848(q)(5)(D)(i)(II) of the Act permits us to take into account 
improvement in the case of performance scores in other performance 
categories. Given that we have in effect waivers of the scoring weight 
for the cost performance category, and of the requirement to specify 
and use cost measures in calculating the MIPS final score for MIPS 
eligible clinicians participating in MIPS APMs, and for the same 
reasons that we initially waived those requirements, we proposed to use 
our authority under section 1115A(d)(1) of the Act for MIPS APMs 
authorized under section 1115A of the Act and under section 1899(f) of 
the Act for the Medicare Shared Savings Program to waive the 
requirement under section 1848(q)(5)(D)(i)(I) of the Act to take 
improvement into account for performance scores in the cost performance 
category beginning with the 2018 MIPS performance period (82 FR 30082).
    We sought comment on this proposal. The following is a summary of 
the public comments we received and our response:
    Comment: Several commenters supported CMS's proposal to waive cost 
improvement scoring as participants in MIPS APMs are already scored and 
reimbursed on their performance on cost/utilization measures under the 
terms of the MIPS APM
    Response: We thank the commenters for their support of our 
proposal.
    Final Action: After considering public comments, we are finalizing 
the policy to waive cost improvement scoring as proposed.
(b) Quality Performance Category
(i) Web Interface Reporters: Shared Savings Program and Next Generation 
ACO Model
(A) Quality Measures
    We finalized in the CY 2017 Quality Payment Program final rule that 
under the APM scoring standard, participants in the Shared Savings 
Program and Next Generation ACO Model would be assessed for the 
purposes of generating a MIPS APM quality performance category score 
based exclusively on quality measures submitted using the CMS Web 
Interface (81 FR 77256, 77261). We also recognized that ACOs in both 
the Shared Savings Program and Next Generation ACO Model are required 
to use the CMS Web Interface to submit data on quality measures, and 
that the measures they are required to report for 2017 were also MIPS 
measures for 2017. We finalized a policy to use quality measures and 
data submitted by the participant ACOs using the CMS Web Interface and 
MIPS benchmarks for these measures to score quality for MIPS eligible 
clinicians in these MIPS APMs at the APM Entity level (81 FR 77256, 
77261). For these MIPS APMs, which we refer to as CMS Web Interface 
reporters going forward, we established that quality performance data 
that are not submitted using the Web Interface, for example, the CAHPS 
for ACOs survey and claims-based measures, will not be included in the 
MIPS APM quality performance category score for 2017. We also 
established a policy, codified at Sec.  414.1370(f)(1), to allow Shared 
Savings Program participant TINs to report quality on behalf of the TIN 
in the event that the ACO Entity fails to report quality on behalf of 
the APM Entity group, and for purposes of scoring under the APM scoring 
standard to treat such participant TINs as unique APM Entities.
(aa) Addition of New Measures
    In the CY 2018 Quality Payment Program proposed rule (82 FR 30082 
through 30083), we proposed to score the CAHPS for ACOs survey in 
addition to the CMS Web Interface measures that are used to calculate 
the MIPS APM quality performance category score for participants in the 
Shared Savings Program and Next Generation ACO Model, beginning in the 
2018 performance period. The CAHPS for ACOs survey is already required 
in the Shared Savings Program and Next Generation ACO Model, and 
including the CAHPS for ACOs survey would better align the measures on 
which

[[Page 53693]]

participants in these MIPS APMs are assessed under the APM scoring 
standard with the measures used to assess participants' quality 
performance under the APM.
    We did not initially propose to include the CAHPS for ACOs survey 
as part of the MIPS APM quality performance category scoring for the 
Shared Savings Program and Next Generation ACO Model because we 
believed that the CAHPS for ACOs survey would not be collected and 
scored in time to produce a MIPS quality performance category score. 
However, operational efficiencies have recently been introduced that 
have made it possible to score the CAHPS for ACOs survey on the same 
timeline as the CAHPS for MIPS survey. Under the proposal, the CAHPS 
for ACOs survey would be added to the total number of quality 
performance category measures available for scoring in these MIPS APMs.
    While the CAHPS for ACOs survey is new to the APM scoring standard, 
the CG-CAHPS survey upon which it is based is also the basis for the 
CAHPS for MIPS survey, which was included on the MIPS final list for 
the 2017 performance period. For further discussion of the CAHPS for 
ACOs survey, and the way it will be scored, we refer readers to section 
II.C.7.a.(2)(b) of this final rule with comment period, which describes 
the CAHPS for MIPS survey and the scoring method that will be used for 
MIPS and the APM scoring standard in the 2018 performance period.
    We noted that although each question in the CAHPS for ACOs survey 
can also be found in the CAHPS for MIPS survey, the CAHPS for ACOs 
survey will have one fewer survey question in the Summary Survey 
Measure entitled ``Between Visit Communication'', which has never been 
a scored measure in the CAHPS for ACOs survey used in the Shared 
Savings Program or Next Generation ACO Model, and which we believe to 
be inappropriate to score for MIPS, as it is not scored under the terms 
of the APM.

       Table 10--Web Interface Reporters: Shared Savings Program and Next Generation ACO Model New Measure
----------------------------------------------------------------------------------------------------------------
                                 NQF/quality        National
         Measure name             number (if        quality            Measure description       Primary measure
                                 applicable)    strategy domain                                      steward
----------------------------------------------------------------------------------------------------------------
CAHPS for ACOs...............  Not Applicable.  Patient/         Consumer Assessment of          Agency for
                                                 Caregiver        Healthcare Providers and        Healthcare
                                                 Experience.      Systems (CAHPS) surveys for     Research and
                                                                  Accountable Care                Quality
                                                                  Organizations (ACOs) in the     (AHRQ).
                                                                  Medicare Shared Savings
                                                                  Program and Next Generation
                                                                  ACO Model ask consumers about
                                                                  their experiences with health
                                                                  care. The CAHPS for ACOs
                                                                  survey is collected from a
                                                                  sample of beneficiaries who
                                                                  get the majority of their
                                                                  care from participants in the
                                                                  ACO, and the questions
                                                                  address care received from a
                                                                  named clinician within the
                                                                  ACO.
                                                                 Survey measures include:--
                                                                  Getting Timely Care,
                                                                  Appointments, and Information
                                                                    --How Well Your Providers
                                                                     Communicate.
                                                                    --Patients' Rating of
                                                                     Provider.
                                                                    --Access to Specialists....
                                                                    --Health Promotion and
                                                                     Education.
                                                                    --Shared Decision Making...
                                                                    --Health Status/Functional
                                                                     Status.
                                                                    --Stewardship of Patient
                                                                     Resources.
----------------------------------------------------------------------------------------------------------------

    We sought comment on this proposal. The following is a summary of 
the public comments we received and our responses:
    Comment: Several commenters supported the proposal.
    Response: We thank commenters for their support of our proposal.
    Comment: One commenter expressed confusion as to whether the CAHPS 
for ACOs survey would be required under the APM scoring standard, or 
whether it is an optional measure.
    Response: Under the APM scoring standard, it is our goal to score 
all measures required under the terms of the APM. As part of the 
quality performance requirements for the Shared Savings Program and the 
Next Generation ACO Model, all participating ACOs are already required 
to report all of the measures included in the CAHPS for ACOs survey. 
Because we are able to score the CAHPS for ACOs survey, and it is 
mandatory under these APMs, it will be scored under the APM scoring 
standard for participants in those APMs. Notwithstanding the fact that 
the CAHPS for ACOs survey is mandatory for Shared Savings Program and 
Next Generation ACO participants, we note that MIPS eligible clinicians 
participating in ACOs will nonetheless be eligible to receive bonus 
points for reporting this measure, which is classified as a high-
priority measure, beginning in 2018.
    Comment: Some commenters objected to the subjective nature of the 
CAHPS for ACOs survey and the difficulty in acting on responses to 
improve quality.
    Response: Under both the Shared Savings Program and Next Generation 
ACO Model, ACOs are required to report on all of the measures included 
in the CAHPS for ACOs survey, and the results of the survey are used to 
assess the quality performance of the ACO. Because the CAHPS for ACOs 
survey is required under the terms of those initiatives, we believe it 
is appropriate to use the CAHPS for ACOs survey for purposes of the APM 
scoring standard.
    Final Action: After considering public comments, we are finalizing 
the policy to score the CAHPS for ACOs survey in addition to the CMS 
Web Interface measures that are used to calculate the MIPS APM quality 
performance category score for participants in the Shared Savings 
Program and Next Generation ACO Model, beginning in the 2018 
performance period, as proposed, in accordance with Sec.  
414.1370(g)(1)(i)(A).
(B) Calculating Quality Scores
    We refer readers to section II.C.7.a.(2) of this final rule with 
comment period for a summary of our final policies related to 
calculating the MIPS quality performance category percent score for 
MIPS eligible clinicians, including APM Entity groups, reporting 
through the CMS Web Interface, and a discussion of our proposed and 
final changes to those policies for the 2018 performance period. The 
changes we are finalizing in section II.C.7.a.(2) of this final rule 
with comment period apply in the same

[[Page 53694]]

manner under the APM scoring standard for Web Interface reporters 
except as otherwise noted in this section of this final rule with 
comment period.
    However, we proposed not to subject Web Interface reporters to a 3 
point floor because we do not believe it is necessary to apply this 
transition year policy to MIPS eligible clinicians participating in 
previously established MIPS APMs (82 FR 30083). We sought comment on 
this proposal.
    Final Action: We received no public comments on this proposal. We 
are finalizing this policy as proposed at Sec.  414.1370(g)(1)(i)(A).
(C) Incentives To Report High Priority Measures
    In the CY 2017 Quality Payment Program final rule, we finalized 
that for CMS Web Interface reporters, we will apply bonus points based 
on the finalized set of measures reportable through the Web Interface 
(81 FR 77291 through 77294). We will assign two bonus points for 
reporting each outcome measure (after the first required outcome 
measure) and for each scored patient experience measure. We will also 
assign one bonus point for reporting each other high priority measure.
    In the CY 2018 Quality Payment Program proposed rule (82 FR 30083), 
we noted that in addition to the measures required by the APM to be 
submitted through the CMS Web Interface, APM Entities in the Medicare 
Shared Savings Program and Next Generation ACO Model must also report 
the CAHPS for ACOs survey, and we proposed that, beginning for the 2020 
payment year forward, participants in the APM Entities may receive 
bonus points under the APM scoring standard for submitting that 
measure. Participants in MIPS APMs, like all MIPS eligible clinicians, 
are also subject to the 10 percent cap on bonus points for reporting 
high priority measures. APM Entities reporting through the CMS Web 
Interface will only receive bonus points if they submit a high priority 
measure with a performance rate that is greater than zero, and provided 
that the measure meets the case minimum requirements.
    Final Action: We received no public comment on this proposal. We 
are finalizing this policy as proposed at Sec.  414.1370(g)(1)(i)(C).
(D) Scoring Quality Improvement
    Beginning in the 2018 performance period, section 
1848(q)(5)(D)(i)(I) of the Act requires us to score improvement for the 
MIPS quality performance category for MIPS eligible clinicians, 
including those participating in MIPS APMs, if data sufficient to 
measure quality improvement are available. We proposed to calculate the 
quality improvement score using the methodology described in the CY 
2018 Quality Payment Program proposed rule for scoring quality 
improvement for MIPS eligible clinicians submitting quality measures 
via the CMS Web Interface (82 FR 30113, 30116-30119) and finalized at 
II.C.7.a.(2). In the CY 2018 Quality Payment Program proposed rule, we 
stated that we believe aligning the scoring methodology used for all 
Web Interface submissions will minimize confusion among MIPS eligible 
clinicians receiving a MIPS score, including those participating in 
MIPS APMs (82 FR 30083).
    The following is a summary of the public comments we received on 
this proposal and our response:
    Comment: Several commenters expressed support for our proposal to 
make quality improvement points available beginning in the 2018 
performance period.
    Response: We thank commenters for their support of our quality 
improvement scoring proposal.
    Final Action: We are finalizing this policy as proposed at Sec.  
414.1370(g)(1)(i)(B).
(E) Total Quality Performance Category Score for Web Interface 
Reporters
    In the 2018 Quality Payment Program proposed rule (82 FR 30083 
through 30084), we proposed to calculate the total quality percent 
score for APM Entities in APMs that require Web Interface reporting 
according to the methodology for scoring MIPS eligible clinicians 
reporting on quality through the CMS Web Interface described in section 
II.C.7.a.(2) of this final rule with comment period.
    We sought comment on our proposed quality performance category 
scoring methodology for Web Interface reporters. The following is a 
summary of the public comments we received and our responses:
    Comment: One commenter expressed confusion as to how quality 
improvement scoring will be calculated at the APM Entity level for MIPS 
eligible clinicians in MIPS APMs.
    Response: APM Entity groups, like other MIPS groups, will receive 
quality improvement scores for any year following a year in which one 
or more members of the APM Entity group was subject to MIPS and 
received a quality score. If the APM Entity group existed in the 
previous performance period and received a quality score, we will use 
that score for the purpose of calculating quality improvement points. 
If the APM Entity group did not exist or receive a quality score but 
some of its participant TIN/NPIs received quality scores in the 
previous performance period, the mean of those scores would be applied 
to the APM Entity group for the purpose of calculating quality 
improvement points. If the APM Entity group did not exist or receive a 
quality score and none of its participant MIPS eligible clinicians 
received quality scores in the previous performance period, no quality 
improvement points will be awarded.
    Final Action: After considering the public comments, we are 
finalizing the policy for calculating the total quality performance 
category score for Web Interface reporters as proposed at Sec.  
414.1370(g)(1)(i)(C).
(ii) Other MIPS APMs
    In the CY 2018 Quality Payment Program proposed rule (82 FR 20084), 
we proposed to define the term Other MIPS APM at Sec.  414.1305 of our 
regulations as a MIPS APM that does not require reporting through the 
Web Interface. We proposed to add this definition as we believe it will 
be useful in discussing our policies for the APM scoring standard. For 
the 2018 MIPS performance period, Other MIPS APMs will include the 
Comprehensive ESRD Care Model, the Comprehensive Primary Care Plus 
Model (CPC+), and the Oncology Care Model.
    We sought comment on this proposal. The following is a summary of 
the public comments we received on this proposal and our responses:
    Comment: One commenter objected to the use of the term Other MIPS 
APM and found the distinction between MIPS APMs and Other MIPS APMs 
confusing.
    Response: We clarify that MIPS APMs are those APMs that meet the 
four criteria of: (1) The APM Entities participate in the APM under an 
agreement with CMS by law or regulation, (2) the APM requires that 
Entities include at least one MIPS eligible clinician on a 
Participation List, (3) the APM bases payment incentives on performance 
(either at the APM Entity or clinician level) on cost/utilization and 
quality measures, and (4) the APM is not either a new APM for which the 
first performance period begins after the first day of the MIPS 
performance period for the year or an APM in the final year of 
operation for which the APM scoring standard is impracticable. Web 
Interface reporters are a subset of MIPS APMs where the terms of the 
APM require participating APM Entities to report quality data using the 
Web Interface. Other MIPS APMs include all MIPS APMs that are

[[Page 53695]]

not Web Interface reporters and are also a subset of MIPS APMs.
    Comment: Some commenters expressed confusion as to how Other MIPS 
APM policies will impact Next Generation ACOs.
    Response: The APM scoring standard applies for MIPS eligible 
clinicians in MIPS APMs. In discussing policies for the APM scoring 
standard, we developed terminology to describe two subcategories of 
MIPS APMs: Web Interface reporters (currently the Shared Savings 
Program and Next Generation ACO Model), and Other MIPS APMs (all other 
MIPS APMs that are not Web Interface reporters). Policies for Other 
MIPS APMs will apply only to MIPS APMs that do not require reporting 
through the Web Interface. For the 2018 performance period, only the 
Shared Savings Program and Next Generation ACO Model are Web Interface 
reporter APMs and therefore are not Other MIPS APMs.
    Final Action: After considering public comments, we are finalizing 
the policy as proposed by defining the term Other MIPS APM at Sec.  
414.1305.
(A) Quality Measures
    In the CY 2017 Quality Payment Program final rule, we explained 
that current MIPS APMs have requirements regarding the number of 
quality measures and measure specifications as well as the measure 
reporting method(s) and frequency of reporting, and have an established 
mechanism for submission of these measures to us within the structure 
of the specific MIPS APM. We explained that operational considerations 
and constraints interfered with our ability to use the quality measure 
data from some MIPS APMs for the purpose of satisfying MIPS data 
submission requirements for the quality performance category for the 
first performance period. We concluded that there was insufficient time 
to adequately implement changes to the current MIPS APM quality measure 
data collection timelines and infrastructure in the first performance 
period to conduct a smooth hand-off to the MIPS system that would 
enable use of quality measure data from these MIPS APMs to satisfy the 
MIPS quality performance category requirements in the first MIPS 
performance period (81 FR 77264). Out of concern that subjecting MIPS 
eligible clinicians who participate in these MIPS APMs to multiple, 
potentially duplicative or inconsistent performance assessments could 
undermine the validity of testing or performance evaluation under the 
MIPS APMs; and that there was insufficient time to make adjustments in 
operationally complex systems and processes related to the alignment, 
submission and collection of APM quality measures for purposes of MIPS, 
we used our authority under section 1115A(d)(1) of the Act to waive 
certain requirements of section 1848(q) of the Act for APMs authorized 
under section 1115A of the Act.
    In the CY 2017 Quality Payment Program final rule, we finalized 
that for the first MIPS performance period only, for MIPS eligible 
clinicians participating in APM Entities in Other MIPS APMs, the weight 
for the quality performance category is zero (81 FR 77268). To avoid 
risking adverse operational or program evaluation consequences for MIPS 
APMs while we worked toward incorporating MIPS APM quality measures 
into scoring for future performance periods, we used the authority 
provided by section 1115A(d)(1) of the Act to waive the quality 
performance category weight required under section 1848(q)(5)(E)(i)(I) 
of the Act for Other MIPS APMs, all of which are currently authorized 
under section 1115A of the Act, and we indicated that with the 
reduction of the quality performance category weight to zero, it was 
unnecessary to establish for these MIPS APMs a final list of quality 
measures as required under section 1848(q)(2)(D) of the Act or to 
specify and use quality measures in determining the MIPS final score 
for these MIPS eligible clinicians. As such, we further waived the 
requirements under sections 1848(q)(2)(D), 1848(q)(2)(B)(i), and 
1848(q)(2)(A)(i) of the Act to establish a final list of quality 
measures (using certain criteria and processes); and to specify and 
use, respectively, quality measures in calculating the MIPS final score 
for the first MIPS performance period.
    In the CY 2017 Quality Payment Program final rule, we anticipated 
that beginning with the second MIPS performance period, the APM quality 
measure data submitted to us during the MIPS performance period would 
be used to derive a MIPS quality performance score for APM Entities in 
all MIPS APMs. We also anticipated that it may be necessary to propose 
policies and waivers of requirements of the statute, such as section 
1848(q)(2)(D) of the Act, to enable the use of non-MIPS quality 
measures in the quality performance category score. We anticipated that 
by the second MIPS performance period we would have had sufficient time 
to resolve operational constraints related to use of separate quality 
measure systems and to adjust quality measure data submission 
timelines. Accordingly, we stated our intention, in future rulemaking, 
to use our section 1115A(d)(1) waiver authority to establish that the 
quality measures and data that are used to evaluate performance for APM 
Entities in Other MIPS APMs would be used to calculate a MIPS quality 
performance score under the APM scoring standard.
    We have since designed the means to overcome the operational 
constraints that prevented us from scoring quality for these MIPS APMs 
under the APM scoring standard in the first MIPS performance period, 
and in the CY 2018 Quality Payment Program proposed rule we proposed to 
adopt quality measures for use under the APM scoring standard, and to 
begin collecting MIPS APM quality measure performance data to generate 
a MIPS quality performance category score for APM Entities 
participating in Other MIPS APMs beginning with the 2018 MIPS 
performance period.
    We sought comment on this proposal. The following is a summary of 
the public comments we received on this proposal and our responses:
    Comment: Some commenters expressed support for our proposal.
    Response: We thank commenters for their support of our proposal.
    Final Action: After considering public comments, we are finalizing 
our proposal to use quality measure performance data reported for 
purposes of the Other MIPS APM to generate a MIPS quality performance 
category score for APM Entities participating in Other MIPS APMs 
beginning with the 2018 MIPS performance period as proposed. We are 
codifying this policy at Sec.  414.1370(g)(1)(ii)(A).
(aa) APM Measures for MIPS
    In the CY 2017 Quality Payment Program final rule, we explained the 
concerns that led us to express our intent to use the quality measures 
and data that apply in MIPS APMs for purposes of the APM scoring 
standard, including concerns about the application of multiple, 
potentially duplicative or inconsistent performance assessments that 
could negatively impact our ability to evaluate MIPS APMs (81 FR 
77246). Additionally, the quality and cost/utilization measures that 
are used to calculate performance-based payments in MIPS APMs may vary 
from one MIPS APM to another. Factors such as the type and quantity of 
measures required, the MIPS APM's particular measure specifications, 
how frequently the measures must be reported, and the mechanisms used 
to collect or submit the measures all add to the diversity in the 
quality and cost/utilization measures used to evaluate performance 
among MIPS APMs. Given

[[Page 53696]]

these concerns and the differences between and among the quality 
measures used to evaluate performance within MIPS APMs as opposed to 
those used more generally under MIPS, in the CY 2018 Quality Payment 
Program proposed rule, we proposed to use our authority under section 
1115A(d)(1) of the Act to waive requirements under section 
1848(q)(2)(D) of the Act, which requires the Secretary to use certain 
criteria and processes to establish an annual MIPS final list of 
quality measures from which all MIPS eligible clinicians may choose 
measures for purposes of assessment, and instead to establish a MIPS 
APM quality measure list for purposes of the APM scoring standard (82 
FR 30084). The MIPS APM quality measure list would be adopted as the 
final list of MIPS quality measures under the APM scoring standard for 
Other MIPS APMs, and would reflect the quality measures that are used 
to evaluate performance on quality within each Other MIPS APM.
    The MIPS APM measure list we proposed in Table 13 of the CY 2018 
Quality Payment Program proposed rule would define distinct measure 
sets for participants in each MIPS APM for purposes of the APM scoring 
standard, based on the measures that are used by the APM, and for which 
data will be collected by the close of the MIPS submission period. The 
measure sets on the MIPS APM measure list would represent all possible 
measures which may contribute to an APM Entity's MIPS score for the 
MIPS quality performance category, and may include measures that are 
the same as or similar to those used by MIPS. However, measures may 
ultimately not be used for scoring if a measure's data becomes 
inappropriate or unavailable for scoring; for example, if a measure's 
clinical guidelines are changed or the measure is otherwise modified by 
the APM during the performance period, the data collected during that 
performance period would not be uniform, and as such may be rendered 
unusable for purposes of the APM scoring standard (82 FR 30091).
    We sought comment on this proposal. The following is a summary of 
comments we received on this proposal and our responses:
    Comment: Several commenters expressed support for the proposed 
requirements for APM quality measures under the APM scoring standard.
    Response: We thank commenters for their support for our proposal to 
use quality measures that are used within Other MIPS APMs for purposes 
of scoring under the APM scoring standard.
    Comment: One commenter voiced concern that CMS would add measures 
to the APM scoring standard measure set outside of notice-and-comment 
rulemaking in order to include all measures used by a MIPS APM.
    Response: We clarify that we will not be scoring performance for 
any measures not included on the MIPS APM quality measure list included 
in each year's proposed rule. Any measures that are added to an Other 
MIPS APM's measure set after the proposed rule has been published will 
not be scored under the APM scoring standard until they have been 
proposed and adopted through notice-and-comment rulemaking in the 
following year.
    Comment: One commenter expressed concern that the time it takes to 
develop and implement new measures upon which eligible clinicians are 
scored may cause delays in the adoption of new innovative technologies 
with value that cannot easily be captured by current measure types, 
particularly among MIPS APM participants.
    Response: We do not believe any policies under the APM scoring 
standard would diminish any existing incentives for the adoption of new 
technologies, or affect the flexibility for APMs to set their own 
incentives for the adoption of such technologies. Furthermore, we 
encourage the public to respond to our annual call for measures, as 
described at section II.C.6.c.(1) of this final rule with comment 
period, to help ensure that appropriate measures are quickly adopted by 
appropriate programs.
    Comment: Several commenters requested more information about the 
way measures and their benchmarks are decided on for purposes of APMs.
    Response: For questions about APM measures and their benchmarks, we 
refer readers to https://qpp.cms.gov/apms/overview or the CMS Measure 
Development Plan: Supporting the Transition to the Quality Payment 
Program 2017 Annual Report, which is available at https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/MACRA-MIPS-and-APMs/2017-CMS-MDP-Annual-Report.pdf. We 
did not address or propose to modify policies relating to the 
development and adoption of measures or benchmarks for purposes of 
individual MIPS APMs.
    Comment: One commenter requested that CMS provide more information 
about reporting requirements for quality measures under the APM scoring 
standard for Other MIPS APMs.
    Response: Under the APM scoring standard, APM Entities will not be 
required to do any additional reporting on quality measures beyond what 
they are already required to report as part of their participation in 
the MIPS APM. Therefore, whatever specific reporting mechanisms and 
measures are required by each MIPS APM will also be used for purposes 
of MIPS under the APM scoring standard.
    Final Action: After considering public comments, we are finalizing 
our proposal to establish a MIPS APM quality measure list for purposes 
of the APM scoring standard at Sec.  414.1370(g)(1)(ii)(A).
(B) Measure Requirements for Other MIPS APMs
    Because the quality measure sets for each Other MIPS APM are 
unique, in the CY 2018 Quality Payment Program proposed rule, we 
proposed to calculate the MIPS quality performance category score using 
Other MIPS APM-specific quality measures (82 FR 30085). For purposes of 
the APM scoring standard, we proposed to score only measures that: (1) 
Are tied to payment as described under the terms of the APM, (2) are 
available for scoring near the close of the MIPS submission period, (3) 
have a minimum of 20 cases available for reporting, and (4) have an 
available benchmark. We discuss our policies for each of these 
requirements for Other MIPS APM quality measures below.
    We sought comment on this proposal. The following is a summary of 
the comments we have received and our responses:
    Comment: Some commenters recommended that CMS exclude three 
additional categories from those that will be used for scoring under 
the APM scoring standard when including Other MIPS APM measures: pay-
for-reporting measures, utilization measures, and measures that are new 
within an APM.
    Response: We clarify that pay-for-reporting measures will not be 
scored because they do not have an available benchmark. As such, we do 
not believe it is necessary to explicitly state that we will exclude 
these measures. Measures that are new within an APM are often pay-for-
reporting in their first year in order to give time for APM 
participants to gain experience with the measure and to establish a 
benchmark; in cases where new measures are immediately pay for 
performance, we believe it would be appropriate to score them because 
the measures themselves would be used under the terms of the APM, and 
to the extent possible it is our goal to align scoring under the APM 
scoring standard with scoring under the terms of the APM. Tying payment 
to cost/utilization is a requirement of all MIPS APMs; cost/

[[Page 53697]]

utilization measures tied to payment are often used by the APMs to meet 
this requirement. Because we will not score MIPS APMs on cost, we 
believe that cost/utilization measures should be scored under the APM 
scoring standard as a means of incentivizing performance within MIPS 
APMs in this MIPS priority area.
    Comment: One commenter voiced concern that the new APM scoring 
standard requirements would be burdensome or confusing for APM Entities 
during the first performance period, and suggested that CMS should 
allow APM Entities to report according to general MIPS quality 
reporting requirements for the APM scoring standard.
    Response: We thank commenters for their concern; however, there 
will be no added reporting burden for participants in MIPS APMs because 
we will be using the quality measure performance data that the APM 
Entity is already submitting as part of the requirements for 
participation in the MIPS APM.
    Final Action: After considering public comments, we are finalizing 
as proposed the policy to only score measures that (1) are tied to 
payment as described under the terms of the APM, (2) are available for 
scoring near the close of the MIPS submission period, (3) have a 
minimum of 20 cases available for reporting, and (4) have an available 
benchmark at Sec.  414.1370(g)(1)(ii)(A)(1) through (4).
(aa) Tied to Payment
    As discussed in the CY 2018 Quality Payment Program proposed rule 
(82 FR 30085), for purposes of the APM scoring standard, we proposed to 
consider a measure to be tied to payment if an APM Entity group will 
receive a payment adjustment or other incentive payment under the terms 
of the APM, based on the APM Entity's performance on the measure.
    We sought comment on this proposal. We did not receive any comments 
on this proposal.
    Final Action: We are finalizing the policy as proposed.
(bb) Available for Scoring
    Some MIPS APM quality measure results are not available until late 
in the calendar year subsequent to the MIPS performance period, which 
would prevent us from including them in the MIPS APM quality 
performance category score under the APM scoring standard due to the 
larger programmatic timelines for providing MIPS eligible clinician 
performance feedback by July and issuing budget-neutral MIPS payment 
adjustments. Consequently, we proposed to only use the MIPS APM quality 
measure data that are submitted by the close of the MIPS submission 
period and are available for scoring in time for inclusion to calculate 
a MIPS quality performance category score (82 FR 30085). Measures are 
to be submitted according to requirements under the terms of the APM; 
the measure data will then be aggregated and prepared for submission to 
MIPS for the purpose of creating a MIPS quality performance category 
score.
    We believe using the Other MIPS APMs' quality measure data that 
have been submitted no later than the close of the MIPS submission 
period and have been processed and made available to MIPS for scoring 
in time to calculate a MIPS quality performance category score is 
consistent with our intent to decrease duplicative reporting for MIPS 
eligible clinicians who would otherwise need to report quality measures 
to both MIPS and their APM. Going forward, these are the measures to 
which we are referring in our proposal to limit scoring to measures 
that are available near the close of the MIPS submission period.
    We sought comment on this proposal. We did not receive any comments 
on this proposal.
    Final Action: We are finalizing the policy as proposed.
(cc) 20 Case Minimum
    We also believe that a 20 case minimum, in alignment with the one 
finalized generally under MIPS in the CY 2017 Quality Payment Program 
final rule, is necessary to ensure the reliability of the measure data 
submitted, as we explained the CY 2017 Quality Payment Program final 
rule (81 FR 77288).
    We proposed that when an APM Entity reports a quality measure that 
includes less than 20 cases, under the APM scoring standard, the 
measure would receive a null score for that measure's achievement 
points, and the measure would be removed from both the numerator and 
the denominator of the MIPS quality performance category percentage. We 
proposed to apply this policy under the APM scoring standard.
    We sought comment on this proposal. The following is a summary of 
the comments we received on this proposal and our responses:
    Comment: One commenter expressed concern as to how failure to 
report the 20 case minimum would impact an APM Entity's score.
    Response: We reiterate that entities that do not reach the 20 case 
minimum for a particular measure will not be penalized for not 
reporting the measure, but instead will receive a null score for that 
particular measure, which will be removed from the numerator and 
denominator when calculating the total quality score, and will 
therefore have neither a positive nor negative impact on the APM 
Entity's overall quality performance category score.
    Final Action: After considering public comments, we are finalizing 
the proposal to establish a 20 case minimum for quality measures under 
the APM scoring standard without change.
(dd) Available Benchmark
    An APM Entity's achievement score on each quality measure would be 
calculated in part by comparing the APM Entity's performance on the 
measure with a benchmark performance score. Therefore, we would need 
all scored measures to have a benchmark available by the time that the 
MIPS quality performance category score is calculated in order to make 
that comparison.
    We proposed that, for the APM scoring standard, the benchmark score 
used for a quality measure would be the benchmark used in the MIPS APM 
for calculation of the performance based payments, where such a 
benchmark is available. If the MIPS APM does not produce a benchmark 
score for a reportable measure that is included on the MIPS APM 
measures list, we would use the benchmark score for the measure that is 
used for the MIPS quality performance category generally (outside of 
the APM scoring standard) for that MIPS performance period, provided 
the measure specifications for the measure are the same under both the 
MIPS final list and the APM measures list. If neither the APM nor MIPS 
has a benchmark available for a reported measure, the APM Entity that 
reported that measure would receive a null score for that measure's 
achievement points, and the measure would be removed from both the 
numerator and the denominator of the quality performance category 
percentage.
    We sought comment on this proposal. The following is a summary of 
the comments we received on this proposal and our responses:
    Comment: One commenter objected to CMS's proposal to remove 
measures from scoring for which no benchmark is available, and instead 
suggested that we assign three points for the measure in alignment with 
general MIPS policy.
    Response: We thank the commenter for the suggestion. In general, we 
have attempted to create consistency between the MIPS and the APM 
scoring standard when practicable. However, in this case doing so would 
be inappropriate

[[Page 53698]]

because APM participants are required to report on all APM measures 
used in the MIPS APM, whereas eligible clinicians reporting under 
general MIPS are given the opportunity to choose six of the measures 
from the MIPS measure set. We believe that it would be unfair to 
require APM Entities to report on measures for which they are unable to 
achieve a score above three, which could significantly impact their 
total quality performance category score. For example, if an APM 
requires that five measures be reported, and an APM Entity received 10 
points on 4 measures, but did not meet the 20 case minimum on the fifth 
measure, the formula for calculating the quality score would be [(10 + 
10 + 10 + 10)/4] = 10 (or, 100 percent), rather than [(10 + 10 + 10 + 
10 + 3)/5] = 8.6 (or, 86 percent).
    Comment: One commenter expressed concern that by limiting the use 
of measures to those for which a benchmark is available, CMS may be 
overly restrictive of new models in their first years of operation, and 
that CMS should instead use any measure for which a benchmark could be 
calculated based on the current performance year.
    Response: To score quality for Other MIPS APMs, we will use any 
available benchmark that is being used by the APM. In the event an APM 
does not have a benchmark for a given measure, we will use MIPS 
benchmarks for that measure if available. With this level of benchmark 
flexibility, we do not anticipate lack of benchmarks will eliminate a 
significant number of measures from the APM scoring standard quality 
calculations.
    Comment: Several commenters objected to scoring Web Interface 
reporters based on the same benchmarks and decile distribution as those 
in Other MIPS APMs reporting through other mechanisms.
    Response: Under the APM scoring standard, Web Interface reporters 
will be scored on a scale unique to Web Interface reporters and based 
on benchmarks generated through the Web Interface. Other MIPS APMs do 
not use the Web Interface and therefore measures will be scored under 
the APM scoring standard's Other MIPS APM scoring methodology using a 
decile distribution unique to each Other MIPS APM.
    Comment: One commenter objected to the use of MIPS measure 
benchmarks in the absence of APM measure benchmarks, despite the 
comparability of the measures, because the effect may be to compare the 
performance of a specific specialty against that of the general health 
care provider population.
    Response: While the use of MIPS benchmarks in the absence of an APM 
benchmark would mean comparing the performance of APM participants to 
the performance of the general MIPS population in order to create the 
measure score, for measures that are used by MIPS as well as MIPS APMs, 
there would not be an advantage or disadvantage given to APM 
participants relative to the general population of MIPS eligible 
clinicians and their scores would simply reflect how they would have 
performed under general MIPS scoring.
    Final Action: After considering public comments, we are finalizing 
the policy with respect to the use of quality performance benchmarks as 
proposed.
(C) Calculating the Quality Performance Category Percent Score
    Eligible clinicians who participate in Other MIPS APMs are subject 
to specific quality measure reporting requirements within these APMs. 
To best align with APM design and objectives, in the CY 2018 Quality 
Payment Program proposed rule, we proposed that the minimum number of 
required measures to be reported for the APM scoring standard would be 
the minimum number of quality measures that are required by the MIPS 
APM and are collected and available in time to be included in the 
calculation for the APM Entity score under the APM scoring standard. 
For example, if an Other MIPS APM requires participating APM Entities 
to report nine of 14 quality measures and the APM Entity fails to 
submit them by the APM's submission deadline, then for the purposes of 
calculating an APM Entity quality performance category score, the APM 
Entity would receive a zero for those measures. An APM Entity that does 
not submit any APM quality measures by the submission deadline would 
receive a zero for its MIPS APM quality performance category percent 
score for the MIPS performance period.
    We also proposed that if an APM Entity submits some, but not all of 
the measures required by the MIPS APM by the close of the MIPS 
submission period, the APM Entity would receive points for the measures 
that were submitted, but would receive a score of zero for each 
remaining measure between the number of measures reported and the 
number of measures required by the APM that were available for scoring.
    For example, if an APM Entity in the above hypothetical MIPS APM 
submits quality performance data on three of the APM's measures, 
instead of the required nine, the APM Entity would receive quality 
points in the APM scoring standard quality performance category percent 
score for the three measures it submitted, but would receive zero 
points for each of the six remaining measures that were required under 
the terms of the MIPS APM. On the other hand, if an APM Entity reports 
on more than the minimum number of measures required to be reported 
under the MIPS APM and the measures meet the other criteria for 
scoring, only the measures with the highest scores, up to the number of 
measures required to be reported under the MIPS APM, would be counted; 
however, any bonus points earned by reporting on measures beyond the 
minimum number of required measures would be awarded.
    If a measure is reported but fails to meet the 20 case minimum or 
does not have a benchmark available, there would be a null score for 
that measure, and it would be removed from both the numerator and the 
denominator, so as not to negatively affect the APM Entity's quality 
performance category score.
    We proposed to assign bonus points for reporting high priority 
measures or measures with end-to-end CEHRT reporting as described for 
general MIPS scoring in the CY 2017 Quality Payment Program final rule 
(81 FR 77297 through 77299).
    We sought comment on these proposals. The following is a summary of 
the public comments we received and our response:
    Comment: Some commenters recommended that CMS require APM Entities 
to report on the same number of measures required under regular MIPS: 
Six.
    Response: We thank commenters for this input. However, we note that 
under the APM scoring standard, eligible clinicians participating in 
MIPS APMs are not required to report any additional measures for 
purposes of MIPS scoring beyond those reported under their MIPS APM, 
and they will only be scored on the minimum number of measures required 
by the APM. The purpose of this policy is to help align incentives 
between the APMs and the Quality Payment Program, and not to emphasize 
performance in one over the other. Given this, it would not be 
appropriate to set a minimum number of measures independent of the 
requirements of the APM.
    Final Action: After considering public comments, we are finalizing 
the policy for calculating the quality performance category score as 
proposed at Sec.  414.1370(g)(1)(ii)(A).

[[Page 53699]]

(aa) Quality Measure Benchmarks
    An APM Entity's MIPS APM quality score will be calculated by 
comparing the APM Entity's performance on a given measure with a 
benchmark performance score. We proposed that the benchmark score used 
for a quality measure would be the benchmark used by the MIPS APM for 
calculation of the performance based payments within the APM, if 
possible, in order to best align the measure performance outcomes 
between MIPS APMs and MIPS generally. If the MIPS APM does not produce 
a benchmark score for a reportable measure that will be available at 
the close of the MIPS submission period, the benchmark score for the 
measure that is used for the MIPS quality performance category 
generally for that performance period would be used, provided the 
measure specifications are the same for both. If neither the APM nor 
MIPS has a benchmark available for a reported measure, the APM Entity 
that reported that measure will receive a null score for that measure's 
achievement points, and the measure will be removed from both the 
numerator and the denominator of the quality performance category 
percentage.
    We proposed that for measures that are pay-for-reporting or which 
do not measure performance on a continuum of performance, we will 
consider these measures to be lacking a benchmark and they will be 
treated as such. For example, if a MIPS APM only requires that an APM 
Entity must surpass a threshold and does not measure APM Entities on 
performance beyond surpassing a threshold, we would not consider such a 
measure to measure performance on a continuum.
    We proposed to score quality measure performance under the APM 
scoring standard using a percentile distribution, separated by decile 
categories, as described in the finalized MIPS quality scoring 
methodology (81 FR 77282 through 77284). For each benchmark, we will 
calculate the decile breaks for measure performance and assign points 
based on the benchmark decile range into which the APM Entity's measure 
performance falls.
    We proposed to use a graduated points-assignment approach, where a 
measure is assigned a continuum of points out to one decimal place, 
based on its place in the decile. For example, as shown in Table 11, a 
raw score of 55 percent would fall within the sixth decile of 41.0 
percent to 61.9 percent and would receive between 6.0 and 6.9 points.

                 Table 11--Benchmark Decile Distribution
------------------------------------------------------------------------
                                      Sample quality    Graduated points
      Sample benchmark decile       measure (percent)   (with no floor)
------------------------------------------------------------------------
Example Benchmark Decile 1........              0-9.9            1.0-1.9
Example Benchmark Decile 2........          10.0-17.9            2.0-2.9
Example Benchmark Decile 3........          18.0-22.9            3.0-3.9
Example Benchmark Decile 4........          23.0-35.9            4.0-4.9
Example Benchmark Decile 5........          36.0-40.9            5.0-5.9
Example Benchmark Decile 6........          41.0-61.9            6.0-6.9
Example Benchmark Decile 7........          62.0-68.9            7.0-7.9
Example Benchmark Decile 8........          69.0-78.9            8.0-8.9
Example Benchmark Decile 9........          79.0-84.9            9.0-9.9
Example Benchmark Decile 10.......           85.0-100               10.0
------------------------------------------------------------------------

    We sought comment on our proposal. The following is a summary of 
the public comments received on this proposal and our response:
    Comment: One commenter voiced concern that comparing performance of 
MIPS APM participants against the performance of eligible clinicians 
assessed under regular MIPS would skew benchmarks and give MIPS APM 
participants an unfair advantage in calculating a MIPS score.
    Response: In circumstances where an APM does not have a benchmark 
available for a measure, but a MIPS benchmark is available, we proposed 
to use the MIPS benchmark to create a measure score. These benchmark 
scores reflect performance of eligible clinicians in the MIPS program, 
against whom MIPS APM participants will ultimately be compared. As 
such, we do not believe the use of these benchmarks is inappropriate in 
this context.
    Final Action: After considering public comments, we are finalizing 
the policy for applying quality measure benchmarks to calculate an APM 
Entity's MIPS quality measure score as proposed.
(bb) Assigning Quality Measure Points Based on Achievement
    For the APM scoring standard quality performance category, we 
proposed that each APM Entity that reports on quality measures would 
receive between 1 and 10 achievement points for each measure reported 
that can be reliably scored against a benchmark, up to the number of 
measures that are required to be reported by the APM (82 FR 30086 
through 30087). Because measures that lack benchmarks or 20 reported 
cases are removed from the numerator and denominator of the quality 
performance category percentage, it is unnecessary to include a point-
floor for scoring of Other MIPS APMs. Similarly, because the quality 
measures reported by the MIPS APM for MIPS eligible clinicians under 
the APM scoring standard are required to be submitted to the APM under 
the terms of the APM, and the MIPS eligible clinicians do not select 
their APM measures, there will be no cap on topped out measures for 
MIPS APM participants being scored under the APM scoring standard, 
which differs from the policy for other MIPS eligible clinicians 
proposed in the CY 2018 Quality Payment Program proposed rule (82 FR 
30101 through 30103).
    Beginning in the 2018 MIPS performance period, we proposed that APM 
Entities in MIPS APMs, like other MIPS eligible clinicians, would be 
eligible to receive bonus points for the MIPS quality performance 
category for reporting on high priority measures or measures submitted 
via CEHRT (for example, end-to-end submission) (82 FR 30109). For each 
Other MIPS APM, we proposed to identify whether any of their available 
measures meets the criteria to receive a bonus, and add the bonus 
points to the quality achievement points. Further, we proposed that the 
total number of awarded bonus points may not exceed 10 percent of the 
APM Entity's total available achievement points for the MIPS quality 
performance category score.

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    To generate the APM Entity's quality performance category 
percentage, achievement points would be added to any applicable bonus 
points, and then divided by the total number of available achievement 
points, with a cap of 100 percent. For more detail on the MIPS quality 
performance category percentage score calculation, we refer readers to 
section II.C.7.a.(2)(j) of this final rule with comment period.
    Under the APM scoring standard for Other MIPS APMs, the number of 
available achievement points would be the number of measures required 
under the terms of the APM and available for scoring multiplied by ten. 
If, however, an APM Entity reports on a required measure that fails the 
20 case minimum requirement, or for which there is no available 
benchmark for that performance period, the measure would receive a null 
score and all points from that measure would be removed from both the 
numerator and the denominator.
    For example, if an APM Entity reports on four out of four measures 
required to be reported by the MIPS APM, and receives an achievement 
score of five on each and no bonus points, the APM Entity's quality 
performance category percentage would be [(5 points x 4 measures) + 0 
bonus points]/(4 measures x 10 max available points), or 50 percent. 
If, however, one of those measures failed the 20 case minimum 
requirement or had no benchmark available, that measure would have a 
null value and would be removed from both the numerator and denominator 
to create a quality performance category percentage of [(5 points x 3 
measures) + 0 bonus points]/(3 measures x 10 max available points), or 
50 percent.
    If an APM Entity fails to meet the 20 case minimum on all available 
APM measures, that APM Entity would have its quality performance 
category score reweighted to zero, as described below.
    We sought comment on these proposals. The following is a summary of 
the public comments we received and our response:
    Comment: One commenter was concerned about the complexity of the 
program and suggested that the addition of additional scoring 
opportunities could become too burdensome for CMS to effectively 
administrate.
    Response: The APM scoring standard was designed to simplify 
administration of MIPS for both eligible clinicians in certain types of 
APMs and for CMS. We believe that we are prepared to effectively 
administer MIPS, including the APM scoring standard. However, as we 
gain additional experience in implementing MIPS, we will continue to 
monitor for opportunities to minimize complexity and reduce burden for 
all parties.
    Final Action: After considering public comments, we are finalizing 
the policy on assigning quality measure points for achievement as 
proposed.
(D) Quality Improvement Scoring
    Beginning in the 2018 MIPS performance period, we proposed to score 
improvement, as well as achievement in the quality performance category 
(82 FR 30087).
    For the APM scoring standard, we proposed that the quality 
improvement percentage points would be awarded based on the following 
formula:

Quality Improvement Score = (Absolute Improvement/Previous Year Quality 
Performance Category Percent Score Prior to Bonus Points)/10

    We sought comment on this proposal. The following is a summary of 
the public comments we received on this proposal and our responses:
    Comment: Several commenters expressed support for this proposal.
    Response: We thank commenters for their support for this proposal.
    Comment: One commenter suggested that rather than declining to 
score quality improvement for the MIPS eligible clinicians who had a 
quality performance category score of 0 in the previous performance 
year, or who did not participate in MIPS in the previous performance 
year, CMS should instead assign a minimum quality performance category 
score of 1 for purposes of calculating an improvement score.
    Response: We thank the commenter for the suggestion. While 
assigning a quality score of 1 in years in which no quality score is 
available would enable us to assign a quality improvement score, it 
would also have the effect of giving all first year participants higher 
quality improvement scores that do not necessarily reflect improvement. 
Instead, with this policy we seek to encourage early and consistent 
participation in MIPS by requiring two years of consecutive 
participation before the quality improvement score can be applied.
    We note that we inadvertently described the formula in error in the 
APM scoring standard section, but provided a cross-reference to the 
discussion and the correct formula under the general MIPS scoring 
standard (82 FR 30096). We are correcting the error in this final rule 
with comment period to clarify and resolve the inconsistency by 
changing the quality improvement score calculation to the following:

Quality Improvement Score = (Absolute Improvement/Previous Year Quality 
Performance Category Percent Score Prior to Bonus Points) * 10

    Final Action: After considering public comments, we are finalizing 
the proposed quality improvement score calculation with the correcte